DOCSLIB.ORG

RX Formulary E1/E4 Drug List PBCBSAK

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

Essentials Formulary E1/E4 Effective 10-01-2021 LIST OF COVERED DRUGS How to use this list: On a high-deductible, health savings account (HSA)? Refer to the E1 formulary. For all covered drugs, once you have satisfied your medical deductible, you will pay your applicable coinsurance until you reach your out-of-pocket maximum for the plan year. The drug tiers do not apply. On a PPO plan? Refer to the E4 formulary. Your drugs fall into 4 tiers: Preferred Generic (1), Preferred Brand (2), Preferred Specialty (3) and Non- Preferred Drugs (4) Please see the chart on page v for information. Have questions? Please call customer service at 800-508-4722 (TTY:711), Monday through Friday, 5 a.m. to 8 p.m. Pacific Time. 052170 (09-28-2021) Essentials (E1/E4) List of Covered Drugs (Formulary) What is the list of covered drugs (Formulary)? This document contains a list of generic, brand and specialty drugs covered under your plan. How is the list of covered drugs developed? The drug list is developed with an independent committee of physicians, pharmacists and other healthcare providers called the Pharmacy and Therapeutics Committee. This independent committee reviews and selects drugs for coverage based on each drugs safety, effectiveness, and cost. The committee meets at least quarterly to review new drugs to market to determine placement on this list and also reviews new information related to safety, effectiveness, and cost for existing drugs to ensure the formulary remains up to date with current medical evidence. How do I use the Formulary? Drugs are listed by categories depending on the type of medical conditions that they are used to treat. If you know what your drug is used for, look for the category name in the list that below. Then look under the category name for your drug. If you are not sure what category to look under, you can also search for the drug in the Index. The Index provides an alphabetical list of all the drugs included in this document. Next to the name of the drug in the Index, you will see the page number where you can find coverage information. Turn to the page listed in the Index and find the name of your drug in the first column of the list. How does this drug list help me understand my drug coverage? Drug coverage is based on your coverage contract. Coverage for a specific drug is subject to the rules outlined in your member booklet. This document will tell you if a drug is included on the formulary attached to your plan. Will this drug list (Formulary) change? This drug list (Formulary) is updated throughout the year. If you are taking a drug and it will be removed from the formulary or moved to a higher cost sharing tier, we will notify you of this change via letter. We also post information on upcoming formulary changes on our website on the “Drug List Changes” page. Are there any restrictions on my coverage? Some covered drugs may have additional requirements or limits on coverage. These can be seen in the column next to the drug name on the list. These requirements and limits may include: • Prior Authorization: some drugs require prior approval before they are covered. ii • Quantity Limits: for some drugs, we limit the amount of the drug that we will cover. For example, we will cover 18 per 30-day supply of zolmitriptan oral tablets. • Step Therapy: for some drugs we require that you first try certain drugs to treat your medical condition before we will cover another drug for that condition. For example, if Drug A and Drug B both treat your medical condition, we may not cover Drug B unless you try Drug A first. If Drug A does not work for you, then we will then cover Drug B. Drugs subject to these restrictions will generally mean that your physician or healthcare provider may need to provide additional information on your medical condition before the drug will be covered at the pharmacy. Information on this process is on our website on the “Drugs Requiring Approval” page. Essentials (E1/E4) Formulary The first column of the chart lists the drug name. Brand name drugs are capitalized (e.g., JANUVIA) and generic drugs are listed in lower-case italics (e.g., metformin oral tablet). The information in the Requirements/Limits column tells you if we have any special requirements for coverage of your drug. iii COVERAGE NOTES ABBREVIATIONS ABBREVIATION DESCRIPTION EXPLANATION Utilization Management Restrictions PA Prior Authorization Restriction You (or your physician) are required to get prior authorization from us before you fill your prescription for this drug. Without prior approval, we may not cover this drug. QL Quantity Limit Restriction We limit the amount of this drug that is covered per prescription, or within a specific time frame. ST Step Therapy Restriction Before we will provide coverage for this drug, you must first try another drug to treat your medical condition. This drug may only be covered if the other drug does not work for you. Other Special Requirements for Coverage LA Limited Access Drug This prescription may be available only at certain pharmacies. EX Excluded Drug This drug is excluded on the Essentials formulary. You will be responsible for the full cost of the drug at the pharmacy. ACA PV Affordable Care Act (ACA) Preventive The Affordable Care Act (ACA) makes Medication certain preventive medications available to you at no cost. Coverage of any medication flagged as “ACA PV” (including over-the- counter (OTC) medications) requires a prescription from a licensed health care provider. OCh Oral Chemo Oral Chemotherapy Drug. Certain oral chemotherapy drugs may be covered under your medical plan. Please check your member booklet for more details. SP Specialty Pharmacy In general, specialty drugs are drugs typically used to treat chronic, complex or rare conditions and may require enhanced clinical support. Specialty Drugs are generally limited to a month supply on dispense. Please check your member booklet for more details. iv The amount you pay for a covered drug will depend on if you have met any applicable deductible for the plan year, if you have met any applicable maximum out of pocket for the plan year and what tier the medication is on. More information on applicable deductibles and maximum out of pockets can be found in your member booklet. Essentials E1 Formulary Drug Tier Includes Formulary Drugs (1, 2, 3, Formulary Drugs include Generic (1), Preferred Brand (2), Preferred 4) Specialty (3) and Non-Preferred (4) Drugs. Medical plan cost shares apply to formulary drugs. Once you have satisfied your medical deductible, you will pay your applicable coinsurance until you reach your out of pocket maximum limit. Essentials E4 Formulary Drug Tier Includes Preferred Generic (1) Tier 1 is the lowest tier and includes preferred generic drugs. Preferred Brand (2) Tier 2 includes preferred brand drugs. Preferred Specialty (3) Tier 3 includes preferred specialty drugs. In general, specialty drugs are drugs typically used to treat chronic, complex, or rare conditions and may require enhanced clinical support. Specialty Drugs are generally limited to a month supply on dispense. Please check your member booklet for more details. Non-Preferred Drugs (4) Tier 4 includes generic, brand and specialty drugs. Non preferred drugs are lower value (more expensive and/or less safe and effective than their alternatives in Tier 1, Tier 2, or Tier 3.) v Drug Name Drug Tier Requirements / Limits ANTI - INFECTIVES ANTIFUNGAL AGENTS amphotericin b injection recon soln 50 mg 4 ANCOBON ORAL CAPSULE 250 MG, 500 MG 4 BREXAFEMME ORAL TABLET 150 MG 4 PA; ST clotrimazole mucous membrane troche 10 mg 1 CRESEMBA ORAL CAPSULE 186 MG 4 PA DIFLUCAN ORAL SUSPENSION FOR 4 RECONSTITUTION 10 MG/ML, 40 MG/ML DIFLUCAN ORAL TABLET 100 MG, 150 MG, 4 200 MG, 50 MG fluconazole oral suspension for reconstitution 10 1 mg/ml, 40 mg/ml fluconazole oral tablet 100 mg, 150 mg, 200 mg, 1 50 mg flucytosine oral capsule 250 mg, 500 mg 4 griseofulvin microsize oral suspension 125 mg/5 1 ml griseofulvin microsize oral tablet 500 mg 1 griseofulvin ultramicrosize oral tablet 125 mg, 250 4 mg itraconazole oral capsule 100 mg 1 itraconazole oral solution 10 mg/ml 4 ketoconazole oral tablet 200 mg 1 NOXAFIL ORAL SUSPENSION 200 MG/5 ML 4 PA (40 MG/ML) NOXAFIL ORAL TABLET,DELAYED EX RELEASE (DR/EC) 100 MG nystatin oral suspension 100,000 unit/ml 1 nystatin oral tablet 500,000 unit 1 ORAVIG BUCCAL MUCO-ADHESIVE EX BUCCAL TABLET 50 MG posaconazole oral tablet,delayed release (dr/ec) 4 100 mg SPORANOX ORAL SOLUTION 10 MG/ML 4 SPORANOX PULSEPAK ORAL CAPSULE 100 4 MG terbinafine hcl oral tablet 250 mg 1 1 Drug Name Drug Tier Requirements / Limits TOLSURA ORAL CAPSULE, SOLID EX DISPERSION 65 MG VFEND ORAL SUSPENSION FOR 4 RECONSTITUTION 200 MG/5 ML (40 MG/ML) VFEND ORAL TABLET 200 MG, 50 MG 4 voriconazole oral suspension for reconstitution 1 200 mg/5 ml (40 mg/ml) voriconazole oral tablet 200 mg, 50 mg 1 ANTIVIRALS abacavir oral solution 20 mg/ml 1 abacavir oral tablet 300 mg 1 abacavir-lamivudine oral tablet 600-300 mg 4 abacavir-lamivudine-zidovudine oral tablet 300- 1 150-300 mg acyclovir oral capsule 200 mg 1 acyclovir oral suspension 200 mg/5 ml 1 acyclovir oral tablet 400 mg, 800 mg 1 adefovir oral tablet 10 mg 1 amantadine hcl oral capsule 100 mg 1 amantadine hcl oral solution 50 mg/5 ml 1 amantadine hcl oral tablet 100 mg 1 APTIVUS ORAL CAPSULE 250 MG 2 atazanavir oral capsule 150 mg, 200 mg, 300 mg 1 ATRIPLA ORAL TABLET 600-200-300 MG EX BARACLUDE ORAL SOLUTION 0.05 MG/ML EX BARACLUDE ORAL TABLET 0.5 MG, 1 MG EX BIKTARVY ORAL TABLET 50-200-25
Recommended publications

  • A History of Birth Control Methods

    Report Published by the Katharine Dexter McCormick Library and the Education Division of Planned Parenthood Federation of America 434 West 33rd Street, New York, NY 10001 212-261-4716 www.plannedparenthood.org Current as of January 2012 A History of Birth Control Methods Contemporary studies show that, out of a list of eight somewhat effective — though not always safe or reasons for having sex, having a baby is the least practical (Riddle, 1992). frequent motivator for most people (Hill, 1997). This seems to have been true for all people at all times. Planned Parenthood is very proud of the historical Ever since the dawn of history, women and men role it continues to play in making safe and effective have wanted to be able to decide when and whether family planning available to women and men around to have a child. Contraceptives have been used in the world — from 1916, when Margaret Sanger one form or another for thousands of years opened the first birth control clinic in America; to throughout human history and even prehistory. In 1950, when Planned Parenthood underwrote the fact, family planning has always been widely initial search for a superlative oral contraceptive; to practiced, even in societies dominated by social, 1965, when Planned Parenthood of Connecticut won political, or religious codes that require people to “be the U.S. Supreme Court victory, Griswold v. fruitful and multiply” — from the era of Pericles in Connecticut (1965), that finally and completely rolled ancient Athens to that of Pope Benedict XVI, today back state and local laws that had outlawed the use (Blundell, 1995; Himes, 1963; Pomeroy, 1975; Wills, of contraception by married couples; to today, when 2000).
  • Table S1: Sensitivity, Specificity, PPV, NPV, and F1 Score of NLP Vs. ICD for Identification of Symptoms for (A) Biome Developm

    Table S1: Sensitivity, Specificity, PPV, NPV, and F1 Score of NLP Vs. ICD for Identification of Symptoms for (A) Biome Developm

    Table S1: Sensitivity, specificity, PPV, NPV, and F1 score of NLP vs. ICD for identification of symptoms for (A) BioMe development cohort; (B) BioMe validation cohort; (C) MIMIC-III; (D) 1 year of notes from patients in BioMe calculated using manual chart review. A) Fatigue Nausea and/or vomiting Anxiety Depression NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.99 (0.93- 0.59 (0.43- <0.00 0.25 (0.12- <0.00 <0.00 0.54 (0.33- Sensitivity 0.99 (0.9 – 1) 0.98 (0.88 -1) 0.3 (0.15-0.5) 0.85 (0.65-96) 0.02 1) 0.73) 1 0.42) 1 1 0.73) 0.57 (0.29- 0.9 (0.68- Specificity 0.89 (0.4-1) 0.75 (0.19-1) 0.68 0.97 (0.77-1) 0.03 0.98 (0.83-1) 0.22 0.81 (0.53-0.9) 0.96 (0.79-1) 0.06 0.82) 0.99) 0.99 (0.92- 0.86 (0.71- 0.94 (0.79- 0.79 (0.59- PPV 0.96 (0.82-1) 0.3 0.95 (0.66-1) 0.02 0.95 (0.66-1) 0.16 0.93 (0.68-1) 0.12 1) 0.95) 0.99) 0.92) 0.13 (0.03- <0.00 0.49 (0.33- <0.00 0.66 (0.48- NPV 0.89 (0.4-1) 0.007 0.94 (0.63-1) 0.34 (0.2-0.51) 0.97 (0.81-1) 0.86 (0.6-0.95) 0.04 0.35) 1 0.65) 1 0.81) <0.00 <0.00 <0.00 F1 Score 0.99 0.83 0.88 0.57 0.95 0.63 0.82 0.79 0.002 1 1 1 Itching Cramp Pain NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.98 (0.86- 0.24 (0.09- <0.00 0.09 (0.01- <0.00 0.52 (0.37- <0.00 Sensitivity 0.98 (0.85-1) 0.99 (0.93-1) 1) 0.45) 1 0.29) 1 0.66) 1 0.89 (0.72- 0.5 (0.37- Specificity 0.96 (0.8-1) 0.98 (0.86-1) 0.68 0.98 (0.88-1) 0.18 0.5 (0-1) 1 0.98) 0.66) 0.88 (0.69- PPV 0.96 (0.8-1) 0.8 (0.54-1) 0.32 0.8 (0.16-1) 0.22 0.99 (0.93-1) 0.98 (0.87-1) NA* 0.97) 0.98 (0.85- 0.57 (0.41- <0.00 0.58 (0.43- <0.00 NPV 0.98 (0.86-1) 0.5 (0-1) 0.02 (0-0.08) NA* 1) 0.72) 1 0.72) 1 <0.00 <0.00 <0.00 F1 Score 0.97 0.56 0.91 0.28 0.99 0.68 1 1 1 *Denotes 95% confidence intervals and P values that could not be calculated due to insufficient cells in 2x2 tables.
  • The National Drugs List

    The National Drugs List

    ^ ^ ^ ^ ^[ ^ The National Drugs List Of Syrian Arab Republic Sexth Edition 2006 ! " # "$ % &'() " # * +$, -. / & 0 /+12 3 4" 5 "$ . "$ 67"5,) 0 " /! !2 4? @ % 88 9 3: " # "$ ;+<=2 – G# H H2 I) – 6( – 65 : A B C "5 : , D )* . J!* HK"3 H"$ T ) 4 B K<) +$ LMA N O 3 4P<B &Q / RS ) H< C4VH /430 / 1988 V W* < C A GQ ") 4V / 1000 / C4VH /820 / 2001 V XX K<# C ,V /500 / 1992 V "!X V /946 / 2004 V Z < C V /914 / 2003 V ) < ] +$, [2 / ,) @# @ S%Q2 J"= [ &<\ @ +$ LMA 1 O \ . S X '( ^ & M_ `AB @ &' 3 4" + @ V= 4 )\ " : N " # "$ 6 ) G" 3Q + a C G /<"B d3: C K7 e , fM 4 Q b"$ " < $\ c"7: 5) G . HHH3Q J # Hg ' V"h 6< G* H5 !" # $%" & $' ,* ( )* + 2 ا اوا ادو +% 5 j 2 i1 6 B J' 6<X " 6"[ i2 "$ "< * i3 10 6 i4 11 6! ^ i5 13 6<X "!# * i6 15 7 G!, 6 - k 24"$d dl ?K V *4V h 63[46 ' i8 19 Adl 20 "( 2 i9 20 G Q) 6 i10 20 a 6 m[, 6 i11 21 ?K V $n i12 21 "% * i13 23 b+ 6 i14 23 oe C * i15 24 !, 2 6\ i16 25 C V pq * i17 26 ( S 6) 1, ++ &"r i19 3 +% 27 G 6 ""% i19 28 ^ Ks 2 i20 31 % Ks 2 i21 32 s * i22 35 " " * i23 37 "$ * i24 38 6" i25 39 V t h Gu* v!* 2 i26 39 ( 2 i27 40 B w< Ks 2 i28 40 d C &"r i29 42 "' 6 i30 42 " * i31 42 ":< * i32 5 ./ 0" -33 4 : ANAESTHETICS $ 1 2 -1 :GENERAL ANAESTHETICS AND OXYGEN 4 $1 2 2- ATRACURIUM BESYLATE DROPERIDOL ETHER FENTANYL HALOTHANE ISOFLURANE KETAMINE HCL NITROUS OXIDE OXYGEN PROPOFOL REMIFENTANIL SEVOFLURANE SUFENTANIL THIOPENTAL :LOCAL ANAESTHETICS !67$1 2 -5 AMYLEINE HCL=AMYLOCAINE ARTICAINE BENZOCAINE BUPIVACAINE CINCHOCAINE LIDOCAINE MEPIVACAINE OXETHAZAINE PRAMOXINE PRILOCAINE PREOPERATIVE MEDICATION & SEDATION FOR 9*: ;< " 2 -8 : : SHORT -TERM PROCEDURES ATROPINE DIAZEPAM INJ.
  • These Highlights Do Not Include All the Information Needed to Use BENZHYDROCODONE and ACETAMINOPHEN TABLETS Safely and Effectively

    These Highlights Do Not Include All the Information Needed to Use BENZHYDROCODONE and ACETAMINOPHEN TABLETS Safely and Effectively

    BENZHYDROCODONE AND ACETAMINOPHEN- benzhydrocodone and acetaminophen tablet KVK-Tech, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BENZHYDROCODONE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for BENZHYDROCODONE AND ACETAMINOPHEN TABLETS. BENZHYDROCODONE AND ACETAMINOPHEN tablets, for oral use, CII Initial U.S. Approval: 1982 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning. Benzhydrocodone and Acetaminophen tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. (5.1) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. (5.2) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.3) Accidental ingestion of Benzhydrocodone and Acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone. (5.3) Prolonged use of Benzhydrocodone and Acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
  • Anti-Inflammatory Effects of Amantadine and Memantine

    Anti-Inflammatory Effects of Amantadine and Memantine

    Journal of Personalized Medicine Communication Anti-Inflammatory Effects of Amantadine and Memantine: Possible Therapeutics for the Treatment of Covid-19? Félix Javier Jiménez-Jiménez 1,* , Hortensia Alonso-Navarro 1 , Elena García-Martín 2 and José A. G. Agúndez 2 1 Section of Neurology, Hospital Universitario del Sureste, Arganda del Rey, E-28500 Madrid, Spain; [email protected] 2 University Institute of Molecular Pathology Biomarkers, UNEx. ARADyAL Instituto de Salud Carlos III, E-10071 Cáceres, Spain; [email protected] (E.G.-M.); [email protected] (J.A.G.A.) * Correspondence: [email protected]; Tel.: +34-636968395 Received: 2 October 2020; Accepted: 6 November 2020; Published: 9 November 2020 Abstract: We have reviewed current data on the anti-inflammatory effects of amantadine and memantine in clinical and in vivo models of inflammation, and we propose that these effects have potential interest for the treatment of the SARS-CoV-2 infection (COVID-19 disease). To that end, we performed a literature search using the PubMed Database from 1966 up to October 31 2020, crossing the terms “amantadine” and “memantine” with “inflammation” and “anti-inflammatory”. Amantadine and/or memantine have shown anti-inflammatory effects in chronic hepatitis C, in neuroinflammation induced by sepsis and by lipopolysaccharides, experimental models of multiple sclerosis, spinal cord injury, and respiratory diseases. Since the inflammatory response is one of the main pathogenetic mechanisms in the progression of the SARS-CoV-2 infection, anti-inflammatory effects of amantadine and memantine could be hypothetically useful in the treatment of this condition. This potential utility deserves further research. Keywords: amantadine; memantine; anti-inflammatory effects; SARS-Cov-2; COVID-19; therapy 1.
  • The Effects of Oral Administration of the Novel Muscarinic Receptor

    The Effects of Oral Administration of the Novel Muscarinic Receptor

    Choi et al. BMC Urology (2020) 20:41 https://doi.org/10.1186/s12894-020-00611-8 RESEARCH ARTICLE Open Access The effects of oral administration of the novel muscarinic receptor antagonist DA- 8010 on overactive bladder in rat with bladder outlet obstruction Jin Bong Choi1, Seung Hwan Jeon2, Eun Bi Kwon3, Woong Jin Bae4, Hyuk Jin Cho2, U-Syn Ha2, Sung-Hoo Hong2, Ji Youl Lee2 and Sae Woong Kim4* Abstract Background: DA-8010 is a novel compound developed for the treatment of overactive bladder (OAB) and urinary incontinence. The aims of this study were to investigate the effects of DA-8010 on OAB in a rat model. Methods: Study animals were divided into the following five groups of seven animals each: a sham-operated control group, a control group with partial bladder outlet obstruction (BOO) (OAB group), and three DA-8010 (doses of 0.3 mg/kg/day, 1 mg/kg/day, and 3 mg/kg/day, respectively) with partial BOO groups. Oral administration of the drugs was continued for 14 days after 2 weeks of partial BOO. After 4 weeks of partial BOO, cystometrography was performed in all groups. Additionally, pro-inflammatory cytokines, Rho-kinases, and histology of the bladder were analyzed. Results: There was a significant increase in the contraction interval and a decrease in contraction pressure in the 3 mg/kg/day DA-8010 group versus those in the OAB group. Rho kinase was also significantly decreased in the DA- 8010 3 mg/kg/day dosage treatment group. The increased ratio of collagen to smooth muscle after partial BOO was significantly attenuated in the DA-8010 3 mg/kg/day dosage group.
  • 204760Orig1s000

    204760Orig1s000

    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204760Orig1s000 OTHER REVIEW(S) MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE: September 16, 2014 FROM: Julie Beitz, MD SUBJECT: Approval Action TO: NDA 204760 Movantik (naloxegol) tablets AstraZeneca Pharmaceuticals LP Summary Naloxegol is an antagonist of opioid binding at the muͲopioid receptor. When administered at the recommended dose levels, naloxegol functions as a peripherallyͲacting opioid receptor antagonist in tissues such as the gastrointestinal tract, thereby decreasing the constipating effects of opioids. Naloxegol is a PEGylated derivative of naloxone and a new molecular entity. Pegylation confers the following properties: naloxegol has reduced passive permeability across membranes compared to naloxone; naloxegol is a PͲglycoprotein (PͲgp) efflux transporter substrate; and naloxegol is orally bioavailable. The reduced passive permeability and PͲgp efflux transporter properties limit CNS entry of naloxegol compared to naloxone. This memo documents my concurrence with the Division of Gastroenterology and Inborn Errors Product’s recommendation for approval of NDA 204760 for Movantik (naloxegol) tablets for the treatment of opioidͲinduced constipation (OIC) in adult patients with chronic nonͲcancer pain. Discussions regarding product labeling, and postmarketing study requirements and commitments have been satisfactorily completed. There are no inspectional issues that preclude approval. Dosing The recommended dose of Movantik (naloxegol) tablets is 25 mg taken once daily in the morning on an empty stomach. Patients who do not tolerate this dose, may reduce the dose to 12.5 mg once daily. Maintenance laxatives should be discontinued prior to initiation of therapy with Movantik.
  • Design and Synthesis of Cyclic Analogs of the Kappa Opioid Receptor Antagonist Arodyn

    Design and Synthesis of Cyclic Analogs of the Kappa Opioid Receptor Antagonist Arodyn

    Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn By © 2018 Solomon Aguta Gisemba Submitted to the graduate degree program in Medicinal Chemistry and the Graduate Faculty of the University of Kansas in partial fulfillment of the requirements for the degree of Doctor of Philosophy. Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Dr. Michael Rafferty Dr. Teruna Siahaan Dr. Thomas Tolbert Date Defended: 18 April 2018 The dissertation committee for Solomon Aguta Gisemba certifies that this is the approved version of the following dissertation: Design and synthesis of cyclic analogs of the kappa opioid receptor antagonist arodyn Chair: Dr. Blake Peterson Co-Chair: Dr. Jane Aldrich Date Approved: 10 June 2018 ii Abstract Opioid receptors are important therapeutic targets for mood disorders and pain. Kappa opioid receptor (KOR) antagonists have recently shown potential for treating drug addiction and 1,2,3 4 8 depression. Arodyn (Ac[Phe ,Arg ,D-Ala ]Dyn A(1-11)-NH2), an acetylated dynorphin A (Dyn A) analog, has demonstrated potent and selective KOR antagonism, but can be rapidly metabolized by proteases. Cyclization of arodyn could enhance metabolic stability and potentially stabilize the bioactive conformation to give potent and selective analogs. Accordingly, novel cyclization strategies utilizing ring closing metathesis (RCM) were pursued. However, side reactions involving olefin isomerization of O-allyl groups limited the scope of the RCM reactions, and their use to explore structure-activity relationships of aromatic residues. Here we developed synthetic methodology in a model dipeptide study to facilitate RCM involving Tyr(All) residues. Optimized conditions that included microwave heating and the use of isomerization suppressants were applied to the synthesis of cyclic arodyn analogs.
  • Summary Analgesics Dec2019

    Summary Analgesics Dec2019

    Status as of December 31, 2019 UPDATE STATUS: N = New, A = Advanced, C = Changed, S = Same (No Change), D = Discontinued Update Emerging treatments for acute and chronic pain Development Status, Route, Contact information Status Agent Description / Mechanism of Opioid Function / Target Indication / Other Comments Sponsor / Originator Status Route URL Action (Y/No) 2019 UPDATES / CONTINUING PRODUCTS FROM 2018 Small molecule, inhibition of 1% diacerein TWi Biotechnology / caspase-1, block activation of 1 (AC-203 / caspase-1 inhibitor Inherited Epidermolysis Bullosa Castle Creek Phase 2 No Topical www.twibiotech.com NLRP3 inflamasomes; reduced CCP-020) Pharmaceuticals IL-1beta and IL-18 Small molecule; topical NSAID Frontier 2 AB001 NSAID formulation (nondisclosed active Chronic low back pain Phase 2 No Topical www.frontierbiotech.com/en/products/1.html Biotechnologies ingredient) Small molecule; oral uricosuric / anti-inflammatory agent + febuxostat (xanthine oxidase Gout in patients taking urate- Uricosuric + 3 AC-201 CR inhibitor); inhibition of NLRP3 lowering therapy; Gout; TWi Biotechnology Phase 2 No Oral www.twibiotech.com/rAndD_11 xanthine oxidase inflammasome assembly, reduced Epidermolysis Bullosa Simplex (EBS) production of caspase-1 and cytokine IL-1Beta www.arraybiopharma.com/our-science/our-pipeline AK-1830 Small molecule; tropomyosin Array BioPharma / 4 TrkA Pain, inflammation Phase 1 No Oral www.asahi- A (ARRY-954) receptor kinase A (TrkA) inhibitor Asahi Kasei Pharma kasei.co.jp/asahi/en/news/2016/e160401_2.html www.neurosmedical.com/clinical-research;
  • Opioids in Palliative Care: Evidence Update May 2014

    Opioids in Palliative Care: Evidence Update May 2014

    Opioids in palliative care Evidence Update May 2014 A summary of selected new evidence relevant to NICE clinical guideline 140 ‘Opioids in palliative care: safe and effective prescribing of strong opioids for pain in palliative care of adults’ (2012) Evidence Update 58 Contents Introduction ................................................................................................................................ 3 Key points .................................................................................................................................. 4 1 Commentary on new evidence .......................................................................................... 5 1.1 Communication .......................................................................................................... 5 1.2 Starting strong opioids – titrating the dose ................................................................ 5 1.3 First-line maintenance treatment ............................................................................... 6 1.4 First-line treatment if oral opioids are not suitable – transdermal patches ................ 6 1.5 First-line treatment if oral opioids are not suitable – subcutaneous delivery ............. 7 1.6 First-line treatment for breakthrough pain in patients who can take oral opioids ...... 7 1.7 Management of constipation ..................................................................................... 8 1.8 Management of nausea ..........................................................................................
  • Updatirg the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

    Updatirg the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

    Updatirg the BeersCriteria for Potentially InappropriateMedication Use in Older Adults Resultsof a US ConsensusPanel of Experts DonnaM.Fich,PhD,RN;lamesW.Cooper,PhD,RPh;WilliamE.Wade,PhannD,FASHP,FCCP; JenniJerL. Waller, PhD;J, RossMaclean, MD; Marh H. Beers,MD Bcckground: Medication toxic effectsand drug- Reruhr: This study identified 48 individual medica- relatedproblems can have profound medical and safety tions or classeso[ medicationsto avoid in older adults consequencesfor older adults and economically affect the and their potential concernsand 20 diseases/conditions health caresystem. The purpose of this initiative was to and medicationsto be avoidedin older adultswith these reviseand update the Beerscriteria for potentially inap- conditions.Of thesepotentially inappropriate drugs, 66 propriate medicationuse in adults 65 yearsand older in wereconsidered by the panelto haveadverse outcomes the United States. of high severity. lYlcthcdr: This study used a modified Delphi method, a Concludonr: This study is an importantupdate of pre- setof proceduresand methodsfor formulating a groupjudg- viously establishedcriteria that have been widely used ment for a subject matter in which precise information is and cited. The application of the Beerscriteria and other Iacking. The criteria reviewed covered 2 types of state- tools for identifying potentially inapproprlate medica- ments: (l) medicationsor medicationclasses that should tion use will continue to enableproviders to plan inter- grnerally be avoidedin persons 65 years or older because
  • Drug Delivery Technology Y

    Drug Delivery Technology Y

    * DDT Nov-Dec 2007 Working 11/9/07 2:29 PM Page 1 November/December 2007 Vol 7 No 10 IN THIS ISSUE Company Profiles 12 Drug Delivery Technologies 58 Excipients, Polymers, Liposomes & Lipids 78 Contract Pharmaceutical & Biological Development Services 83 Machinery & Laboratory Equipment and Software 96 Technology Showcase 102 The science & business of specialty pharma, biotechnology, and drug delivery www.drugdeliverytech.com * DDT Nov-Dec 2007 Working 11/9/07 2:39 PM Page 2 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 3 * DDT Nov-Dec 2007 Working 11/9/07 2:40 PM Page 4 November/December 2007 Vol 7 No 10 PUBLISHER/PRESIDENT Ralph Vitaro EXECUTIVE EDITORIAL DIRECTOR Dan Marino, MSc [email protected] CREATIVE DIRECTOR Shalamar Q. Eagel CONTROLLER Debbie Carrillo CONTRIBUTING EDITORS Cindy H. Dubin Debra Bingham Jason McKinnie TECHNICAL OPERATIONS Mark Newland EDITORIAL SUPPORT Nicholas D. Vitaro ADMINISTRATIVE SUPPORT Kathleen Kenny Corporate/Editorial Office 219 Changebridge Road, Montville, NJ 07045 Tel: (973)299-1200 Fax: (973) 299-7937 www.drugdeliverytech.com Advertising Sales Offices East & Midwest Victoria Geis - Account Executive Coming in 2008 Cheryl S. Stratos - Account Executive 103 Oronoco Street, Suite 200 Alexandria, VA 22314 Tel: (703) 212-7735 Drug Delivery Weekly & Fax: (703) 548-3733 E-mail: [email protected] Specialty Pharma News E-mail: [email protected] West Coast Warren De Graff Western Regional Manager 818 5th Avenue, Suite 301 San Rafael, CA 94901 Tel: (415) 721-0644 Fax: (415) 721-0665 E-mail: [email protected] 0 The weekly electronic newsletter from the publishers of Drug 1 International o N Delivery Technology and Specialty Pharma will provide over 12,000 Ralph Vitaro 7 219 Changebridge Road l o subscribers with the latest news of business deals, alliances, and V Montville, NJ 07045 Tel: (973) 299-1200 7 technology breakthroughs from the pharmaceutical, specialty 0 Fax: (973) 299-7937 0 2 pharmaceutical, drug delivery, and biotechnology industries.