Attention Deficit Disorder Focus Turns to Side Effects

Total Page:16

File Type:pdf, Size:1020Kb

Attention Deficit Disorder Focus Turns to Side Effects September 20, 2018 Attention deficit disorder focus turns to side effects Jonathan Gardner Limiting abuse and reducing risks are the differentiating factors for projects from Kempharm and Supernus. Attention deficit/hyperactivity disorder has been ceded largely to generics and small speciality pharma groups, as the field has moved towards longer-duration agents and improving side effects, often by repurposing existing molecules. Two late-stage companies exemplify this trend, with Kempharm nearing submission for its stimulant KP415, and Supernus expecting pivotal data by year-end for its non-stimulant SPN-812. Kempharm has reported human abuse potential data for KP415, a prodrug of Ritalin, which could clear the way for US FDA submission and potential licensing deals. Supernus, meanwhile, has completed enrolment into three of its four phase III trials ahead of schedule. The company needs SPN-812 to be free of liver and cardiovascular risk, a problem that kept Lilly's similarly acting product, Strattera, from becoming a big seller. Thanks to blockbusters like Adderall, Ritalin, Concerta and, most recently, Vyvanse, ADHD grew to a $5.5bn category in 2017. However, the entry of generic drugs is taking its toll and only Vyvanse is forecast to exceed $1bn in sales this year, according to EvaluatePharma’s consensus of sellside analyst. Forecast for marketed ADHD products Sales ($m) Product Company Pharmacology class 2018e 2020e 2022e 2024e Dopamine agonist & Vyvanse Shire norepinephrine 2,129 2,267 2,374 1,631 reuptake inhibitor Mydayis Shire Psychostimulant 74 242 352 443 Johnson & Concerta Psychostimulant 658 524 450 421 Johnson Methylphenidate Teva Psychostimulant 481 374 302 234 (Ritalin generic) Norepinephrine Strattera Lilly 441 263 227 187 reuptake inhibitor Alpha 2A adrenoceptor Intuniv Shionogi 39 92 137 172 agonist Adderall XR Shire Psychostimulant 308 185 138 120 Cotempla XR- Neos Psychostimulant 21 59 87 114 ODT Therapeutics Neos Adzenys XR-ODT Psychostimulant 28 65 90 109 Therapeutics Metadate CD UCB Psychostimulant 94 92 92 92 Total (all marketed products) 4,819 4,606 4,676 3,937 Source: EvaluatePharma. In addition to generics, concerns about stimulant abuse and overmedication have limited enthusiasm for ADHD research, although the sector is expected to bounce back thanks to Shire’s latest entry, Mydayis, along with assets from Supernus, Kempharm and Sumitomo Dainippon Pharma, which are expected to drive new growth. Stimulants like Ritalin and Mydayis are viewed as more effective than norepinephrine reuptake inhibitors like Strattera, despite side effects with the former that can include sleep disturbances, anxiety, delayed growth, tics and irritability when drugs wear off – hence the desire for longer-acting agents. In addition, Ritalin and others can result in feelings of euphoria, which can lead to abuse. Thus, data earlier this week with Kempharm’s KP415 (serdexmethylphenidate) were key for submission to the US FDA. The prodrug, delivered intranasally, resulted in lower “drug liking” scores than did methylphenidate, the active ingredient in Ritalin. The company hopes that these data can be included in the label if the project is approved, and that they will result in less restrictive regulation by the US Drug Enforcement Administration. Waiting in the wings: late-stage ADHD projects Sales ($m) Product Company Pharma class 2018e 2020e 2022e 2024e Submitted 5-HT, dopamine & Sumitomo norepinephrine SEP-225289 Dainippon 16 132 212 284 reuptake inhibitor Pharma (SNRI) Phase III Norepinephrine SPN 812 Supernus - 21 165 293 reuptake inhibitor SPN-810 Supernus Dihydroindolone - 2 137 289 KP415 Kempharm Psychostimulant - 86 183 247 5-HT, dopamine & Centanafadine Otsuka norepinephrine - 15 44 58 SR Holdings reuptake inhibitor (SNRI) Total 16 256 741 1,171 Source: EvaluatePharma. Kempharm’s chief executive, Travis Mickle, said the company could submit its application to the FDA as early as the first quarter of next year. He added that a “competitive” partnering process for KP415 should be completed by the end of the year. Non-stimulant Meanwhile, Supernus is banking on improving the track record of non-stimulant agents with SPN-812, an extended-release version of viloxazine hydrochloride, which Astrazeneca marketed for depression in Europe under the brand name Emovit. In a presentation to the Wells Fargo healthcare conference earlier this month, Supernus's chief executive, Jack Khattar, said non-stimulants represented 8% of all US prescriptions written, and there was “no reason” for the share to be that small. “If you have a choice as a parent you would always choose a non-stimulant,” he said. That will, of course, depend on the safety profile. While SPN-812 probably will not be able to avoid getting a black box for suicide ideation, like most antidepressants, it might be able to differentiate itself by avoiding side effects seen with stimulant-based drugs like decreased appetite and weight, irritability and insomnia – provided, of course, that it passes liver and cardiovascular safety tests. Three of four phase III trials have completed enrolment – those testing low and high doses in patients aged 6- 11, and a low-dose study in patients aged 12-17. A high-dose adolescent trial is still enrolling and will not read out until 2019. A second Supernus project, SPN-810, is targeting impulse aggression in ADHD. This candidate consists of an old antipsychotic called molindone. A Mizuho analyst, Irina Koffler, regards this as a higher-risk project, in part because the measurement tool used in trials consists of a caregiver diary that has not been fully validated by regulators. Another ADHD candidate in the non-stimulant category is SEP-225289 (dasotraline hydrochloride) from Sumitomo Dainippon Pharma, a project that came to the Japanese group from its 2009 buyout of Sepracor, which is now known as the subsidiary Sunovion. Dasotraline received a complete response letter in August, with a request for more clinical data, suggesting that launch would be delayed for some time. Dasotraline showed improvement in ADHD symptoms in children, but missed in adults. Otsuka's centanafadine hydrochloride will not immediately compete with Supernus as the former is being tested in adult ADHD. Development of this project has been slow, as the first phase I trials took place in 2012. As of the end of July, three phase III trials were listed on clinicaltrials.gov with a combined 1,620 patients. Development of central nervous system drugs is one of the riskier areas of drug research, and since ADHD remains one of the more controversial conditions, owing to worries about overdiagnosis and medication abuse, it is no surprise that big companies are reluctant to invest in R&D. Making existing products better and repurposing older drugs represents incremental innovation, but since so many patients are dissatisfied with their treatments there is room for more dynamic improvements. More from Evaluate Vantage Evaluate HQ 44-(0)20-7377-0800 Evaluate Americas +1-617-573-9450 Evaluate APAC +81-(0)80-1164-4754 © Copyright 2021 Evaluate Ltd..
Recommended publications
  • Drug Information Center Highlights of FDA Activities
    Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device.
    [Show full text]
  • Attention-Deficit Hyperactivity Disorder (ADHD) Stimulant Step Therapy
    Policy: Attention-Deficit Hyperactivity Disorder (ADHD) Annual Review Date: Stimulant Step Therapy Policy 03/18/2021 Last Revised Date: 06/17/2021 OVERVIEW All of the long-acting stimulants are indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Some products are also indicated for the treatment of narcolepsy. Vyvanse is the only stimulant medication indicated for the treatment of binge eating disorder (BED). Approval for this indication was based on two 12-week randomized, double- blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (n = 374 and n = 350) with moderate to severe BED. Patients from both studies on Vyvanse had a statistically significantly greater reduction from baseline in mean number of binge days/week at Week 12. All of these products have abuse potential and are Schedule II controlled substances. POLICY STATEMENT A step therapy program has been developed to encourage use of one Preferred product prior to the use of a Non-Preferred product. If the step therapy rule is not met for a Non-Preferred agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration. Automation: Patients with a history of one Preferred drug within the 130-day look-back period are excluded from step therapy. Preferred Medications: • Generic amphetamine/dextroamphetamine extended-release capsules (generics to Adderall XR) • Generic dexmethylphenidate extended-release capsules (generics
    [Show full text]
  • PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities &
    PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs By: Travis Mickle, PhD INTRODUCTION one or more of the ADME categories — Absorption, Distribution, Metabolism, and Excretion — with the goal being the creation of Attention-deficit/hyperactivity disorder (ADHD) is a neuro- a new chemical entity (NCE) that optimizes the performance, util- logical disorder associated with an ongoing pattern of inattention, ity, and potential life-cycle management of the parent drug. hyperactivity, and/or impulsivity that may impede, for example, cognitive and social functioning, and as well as mental growth and development. Since 1937, more than 25 different products ADHD THERAPEUTIC MARKET have been approved by the FDA to treat ADHD. Despite the many pharmacological advances, there is still no optimal treatment of The Centers for Disease Control and Prevention noted in a this condition, leading prescribers and patients to press for im- 2016 report from the National Survey of Children’s Health that provements that address key shortcomings with currently available 6.1 million, or 9.4% of children aged 4 to 17, suffer from ADHD. ADHD medications. Duration of efficacy, consistency of drug ex- Yet, of all children 2 to 17 years of age that may qualify to take posure and effect, onset of action, and lower abuse potential are ADHD medication, only about 317,000 (or 1 in 20) are currently just some of the key attributes that new technologies are seeking being treated. Globally, there are a reported 175 million cases to address. of ADHD in people 5 to 44 years old, and the forecast indicates In the quest for the optimal ADHD medication, leading re- that this number will rise to more than 185 million by 2025.
    [Show full text]
  • Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And
    Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Rules and Regulations 24487 that authority because it addresses an (1) With a switch unit serial number (S/N) Branch, send it to the attention of the person unsafe condition that is likely to exist or 1413, 1414, 1415, 1424, 1428, 1430, 1432, or identified in paragraph (i)(1) of this AD. develop on helicopters identified in this 1433 installed, or Information may be emailed to: 9-AVS-AIR- rulemaking action. (2) With a missing or illegible switch unit [email protected]. S/N or if the S/N cannot be determined, (2) Before using any approved AMOC, Regulatory Findings installed. notify your appropriate principal inspector, Note 1 to paragraph (c): Helicopters with or lacking a principal inspector, the manager This AD will not have federalism a 206L–1+ designation are Model 206L–1 of the local flight standards district office/ implications under Executive Order helicopters. Helicopters with a 206L–3+ certificate holding district office. 13132. This AD will not have a designation are Model 206L–3 helicopters. (i) Related Information substantial direct effect on the States, on Note 2 to paragraph (c): The switch unit the relationship between the national is located on the aft fuel boost pump (1) For more information about this AD, government and the States, or on the assembly. The P/N and S/N for the switch contact Hal Jensen, Aerospace Engineer, unit could be on the outside face of the Operational Safety Branch, FAA, 950 distribution of power and L’Enfant Plaza N SW, Washington, DC 20024; responsibilities among the various attachment flange, in the cross hatched area of the switch unit.
    [Show full text]
  • Joel L. Young, M.D
    Joel L. Young, M.D. 441 South Livernois Road, Suite 100 Rochester Hills, Michigan 48307 Phone: 248-608-8800 / Fax: 248-608-2490 / E-mail: [email protected] Professional History 2000 – Present: Chief Medical Officer and Founder, Clinical Trials Group at the Rochester Center for Behavioral Medicine, Rochester Hills, MI 1993 – Present: Medical Director and Founder, Rochester Center for Behavioral Medicine, Rochester Hills, MI (www.rcbm.net). 2008 (Current): Clinical Associate Professor of Psychiatry, Wayne State University, Detroit, MI. 2000 – 2007: Medical Director, Crittenton Network for Behavioral Health, Rochester, MI. 2000 – 2002: Chief of Staff, Department of Psychiatry, Crittenton Hospital, Rochester, MI. July, 1993 – 1997: Medical Director, Psychiatric Emergency Services, Crittenton Hospital. July, 1992 – June, 1993: Chief Resident of Adult Services, Department of Psychiatry, University of Michigan Hospitals, Ann Arbor, MI. Oct. 1991-Sept. 1993: Unit Psychiatrist, Bon Secours Adolescent Mental Health Unit, Grosse Pointe, MI. August, 1991 – 1996: Consulting Psychiatrist, Beacon Hill Clinic, Birmingham, MI. July, 1991 – June, 1992: Consulting Psychiatrist, Washtenaw County Community Mental Health Services, Ann Arbor, MI. July, 1990 – June, 1992: House Officer, Department of Psychiatry, University of Michigan Hospitals. June, 1989 – June, 1990: Intern, Departments of Internal Medicine, Pediatrics and Psychiatry, University of Michigan Hospitals. Boards 2018 Fellow: American Board of Psychiatry and Neurology 2017 Re-certification of Geriatric Qualifications by the American Board of Psychiatry and Neurology through 2027. 2017 Re-certification of Forensic Qualifications by the American Board of Psychiatry and Neurology through 2027 2014 Re-Certification by the American Board of Psychiatry and Neurology 2007 Re-certification by the American Board of Adolescent Psychiatry.
    [Show full text]
  • Supported by an Educational Grant from Sunovion Pharmaceuticals Inc. Faculty
    Supported by an educational grant from Sunovion Pharmaceuticals Inc. Faculty Leslie Citrome, MD, MPH C. Brendan Montano, MD Clinical Professor of Psychiatry and CT Clinical Research Behavioral Sciences Director, Principal Investigator New York Medical College Private Practice, Internal Medicine Valhalla, New York Cromwell, Connecticut Faculty Disclosure • Dr. Citrome: Consultant—Acadia, Alkermes, Allergan, Intra-Cellular Therapeutics, Janssen, Lundbeck, Merck, Neurocrine, Noven, Osmotica, Otsuka, Pfizer, Shire, Sunovion, Takeda, Teva, Vanda; Royalties—Springer Healthcare (book), UpToDate (reviewer), Wiley (Editor in Chief, International Journal of Clinical Practice); Shareholder (and spouse)—Bristol-Myers Squibb, Eli Lilly, J & J, Merck, Pfizer; Speaker—Acadia, Alkermes, Allergan, Janssen, Lundbeck, Merck, Neurocrine, Otsuka, Pfizer, Shire, Sunovion, Takeda, Teva. • Dr. Montano: Consultant—Allergan, Shire/Takeda Pharmaceutical Company Ltd., Sunovion Pharmaceuticals Inc., Arbor Pharmaceuticals Ltd.; Research Support—Allergan, Avanir, Sunovion Pharmaceuticals Inc., Tonix, BioHaven, Axsome Therapeutics, Arbor Pharmaceuticals Ltd.; Speakers Bureau— Allergan, Shire/Takeda Pharmaceutical Company Ltd., Arbor Pharmaceutical Ltd. Disclosure • The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational use(s) of drugs, products, and/or devices (any use not approved by the US Food and Drug Administration). – The off-label and investigational use of antidepressants, topiramate,
    [Show full text]
  • Horizon Scanning Status Report June 2019
    Statement of Funding and Purpose This report incorporates data collected during implementation of the Patient-Centered Outcomes Research Institute (PCORI) Health Care Horizon Scanning System, operated by ECRI Institute under contract to PCORI, Washington, DC (Contract No. MSA-HORIZSCAN-ECRI-ENG- 2018.7.12). The findings and conclusions in this document are those of the authors, who are responsible for its content. No statement in this report should be construed as an official position of PCORI. An intervention that potentially meets inclusion criteria might not appear in this report simply because the horizon scanning system has not yet detected it or it does not yet meet inclusion criteria outlined in the PCORI Health Care Horizon Scanning System: Horizon Scanning Protocol and Operations Manual. Inclusion or absence of interventions in the horizon scanning reports will change over time as new information is collected; therefore, inclusion or absence should not be construed as either an endorsement or rejection of specific interventions. A representative from PCORI served as a contracting officer’s technical representative and provided input during the implementation of the horizon scanning system. PCORI does not directly participate in horizon scanning or assessing leads or topics and did not provide opinions regarding potential impact of interventions. Financial Disclosure Statement None of the individuals compiling this information have any affiliations or financial involvement that conflicts with the material presented in this report. Public Domain Notice This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. All statements, findings, and conclusions in this publication are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI) or its Board of Governors.
    [Show full text]
  • Psychiatric Medication Update Objectives Abbreviations
    3/30/2021 Psychiatric Medication Update Kara Gagnon, PharmD, BCPS, BCPP Pharmacy & Behavioral Health Programs Manager Objectives Identify newly approved psychiatric medications Discuss medications currently in the pipeline Review pertinent FDA MedWatch Alerts Evaluate new treatment guidelines for schizophrenia Abbreviations ADHD: Attention Deficit Hyperactivity Disorder AP: Antipsychotic CNS: Central Nervous System FDA: Food and Drug Administration FGA: First Generation Antipsychotic SGA: Second Generation Antipsychotic VMAT2: Vesicular monoamine transporter 2 1 3/30/2021 FDA Drug Approval Process ✓ Drug developed ✓ Animals tested ✓ Investigational New Drug (IND) application ✓ Phase 1 → Phase 2 → Phase 3 trials ✓ Review meeting: FDA + drug sponsor ✓ New Drug Application ✓ FDA NDA Review ✓ Drug Labeling ✓ Manufacturer facility inspection ✓ Drug Approval ✓ Post-Marketing monitoring Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download FDA Drug Approval Process Faster Approval Options ➢ Accelerated Approval ➢ Fast Track Prescription Drug User Fee Act (1992) FDA MedWatch ➢ Voluntary system for physicians and consumers to report adverse events Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download AzstarysTM (serdexmethylphenidate/dexmethylphenidate) FDA Approval: March 2, 2021 CNS stimulant for treatment of ADHD in patients 6 years of age and older Norepinephrine dopamine reuptake inhibitor; Schedule II substance KemPharm, Inc. ➢ LAT® (Ligand Activated Therapy) technology Azstarys. Package Insert. KemPharm Inc. 2021. 2 3/30/2021 AzstarysTM (serdexmethylphenidate/dexmethylphenidate) Novel once-daily oral capsule ➢ First and only product with dexmethylphenidate prodrug Three strengths available ➢ 26.1mg/5.2mg, 39.2mg/7.8mg, 52.3mg/10.4mg Warnings & Precautions ➢ Abuse/dependence, cardiovascular, psychiatric, growth suppression Azstarys.
    [Show full text]
  • (KPIC) PPO and Out-Of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier
    Kaiser Permanente Insurance Company (KPIC) PPO and Out-of- Area Indemnity (OOA) Drug Formulary with Specialty Drug Tier This Drug Formulary was updated: September 1, 2021 NOTE: This drug formulary is updated often and is subject to change. Upon revision, all previous versions of the drug formulary are no longer in effect. This document contains information regarding the drugs that are covered when you participate in the California Nongrandfathered PPO and Out-of- Area Indemnity (OOA) Health Insurance Plans with specialty drug tier offered by Kaiser Permanente Insurance Company (KPIC) and fill your prescription at a MedImpact network pharmacy. Access to the most current version of the Formulary can be obtained by visiting kp.org/kpic-ca-rx-ppo-ngf. For help understanding your KPIC insurance plan benefits, including cost sharing for drugs under the prescription drug benefit and under the medical benefit, please call 1-800-788-0710 or 711 (TTY) Monday through Friday, 7a.m. to 7p.m. For help with this Formulary, including the processes for submitting an exception request and requesting prior authorization and step therapy exceptions, please call MedImpact 24 hours a day, 7 days a week, at 1-800-788-2949 or 711 (TTY). For cost sharing information for the outpatient prescription drug benefits in your specific plan, please visit: kp.org/kpic-ca-rx-ppo-ngf. For help in your preferred language, please see the Kaiser Permanente Insurance Company Notice of Language Assistance in this document. KPIC PPO NGF Table of Contents Informational Section................................................................................................................................2
    [Show full text]
  • Attention Deficit Hyperactivity Disorder Stimulant Medications
    Cigna National Formulary Coverage Policy Step Therapy Attention Deficit Hyperactivity Disorder Stimulant Medications Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 14123 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 4 References .......................................................... 5 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]
  • Psychiatric Medication Update
    Psychiatric Medication Update Jeffrey Bowers R.Ph., BCPP Clinical Psychiatric Pharmacist Cox North Hospital Pharmacy Springfield Missouri Objectives Discuss the meaning of New Medication Review new medications Learn to evaluate medications A New Medication for Weight Loss What does that mean? Obesity is now “cured”? For some patients, obesity is “cured”? https://contrave.com/about/ Usual dosage: Two tablets (naltrexone 16 mg/bupropion 180 mg) twice daily Contrave Contrave (bupropion/naltrexone) is a combination product used to promote and maintain weight loss in obese adults or overweight adults who have weight related medical problems. Contrave is the most popular opioid antagonist/atypical antidepressant combinations. There are currently no generic alternatives to Contrave. GoodRx: https://www.goodrx.com/contrave?dosage=8mg-90mg&form=tablet&label_override=Contrave&quantity=120&sort_type=popularity Pharmacology Demystified How does naltrexone work? New Drug? A New Drug Hits The Market The Drug Development Process Step 1: Discovery and Development Step 2: Preclinical Research Step 3: Clinical Research Step 4: FDA Drug Review Step 5: FDA Post-Market Drug Safety Monitoring https://www.fda.gov/patients/drug-development-process/step-5-fda-post-market-drug-safety-monitoring Phase 1 Trial Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Length of Study: Several months Purpose: Safety and dosage Gather information about how a drug interacts with the human body Researchers adjust dosing schemes
    [Show full text]
  • Corium Launches Innovative ADHD Treatment AZSTARYSTM (Serdexmethylphenidate and Dexmethylphenidate) in the U.S
    CORIUM PRESS RELEASE AZSTARYS LAUNCH ANNOUNCEMENT Corium Launches Innovative ADHD Treatment AZSTARYSTM (serdexmethylphenidate and dexmethylphenidate) in the U.S. for Patients Age 6 Years and Older AZSTARYS is the First and Only Product Containing Prodrug of Dexmethylphenidate Unique formulation provides rapid and extended duration symptom control Boston, MA, July 21, 2021 (PR NEWSWIRE) – Corium, Inc., a commercial-stage biopharmaceutical company leading the development and commercialization of novel central nervous system (CNS) therapies, announces that the innovative AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), is now available in the U.S. for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged 6 years and older. AZSTARYS, approved by the U.S. Food and Drug Administration (FDA) in March 2021, is the first and only product containing SDX, an extended-release oral prodrug of d-MPH. AZSTARYS is available as a once-daily oral capsule in three doses. Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will lead the U.S. commercialization of AZSTARYS. AZSTARYS, classified by the U.S. Drug Enforcement Administration as a Schedule II therapy, includes a combination of 70 percent extended-release prodrug of d-MPH SDX (Schedule IV) and 30 percent immediate-release d-MPH (Schedule II). The Prescribing Information for AZSTARYS includes a Boxed Warning stating CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. “The launch of AZSTARYS provides patients with ADHD, their caregivers, and their clinicians with a first-of-its-kind treatment that offers both rapid and extended ADHD symptom improvement because of the dual action of its formulation using the prodrug SDX with IR MPH,” said Perry J.
    [Show full text]