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(12) Patent Application Publication (10) Pub. No.: US 2011/0195996 A1 Darwish Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2011/0195996 A1 Darwish Et Al US 2011 0195996A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0195996 A1 Darwish et al. (43) Pub. Date: Aug. 11, 2011 (54) TRANSMUCOSAL TREATMENT METHODS (60) Provisional application No. 60/925,981, filed on Apr. IN PATIENTS WITH MUCOSITIS 24, 2007. Publication Classification (75) Inventors: Mona Darwish, Malvern, PA (US); Philmore Robertson, JR., West (51) Int. Cl. Chester, PA (US) A6II 3/4468 (2006.01) A6IP 29/00 (2006.01) (73) Assignee: CEPHALON, INC., Frazer, PA (52) U.S. Cl. ........................................................ S14/329 (US) (57) ABSTRACT (21) Appl. No.: 13/089,578 In accordance with the invention is an fentanyl-containing dosage form designed for transmucosal delivery which (22) Filed: Apr. 19, 2011 includes both an effervescent couple and a pH adjusting Sub stance which can be administered to patients suffering from both pain and mucositis. Also provided is a method of treating Related U.S. Application Data pain in a patient having mild oral mucositis by administering (63) Continuation of application No. 12/150,055, filed on a fentanyl-containing dosage form designed for transmucosal Apr. 24, 2008, now abandoned. delivery. Patent Application Publication Aug. 11, 2011 US 2011/O195996 A1 Absorption phase 1. O 0. 1. 1. 2 3 4 Time after dose administration, hours Mucositis patients (tma= 25.0 min) Non-mucositis patients (tmax = 22.5 min) US 2011/0195996 A1 Aug. 11, 2011 TRANSMUCOSAL TREATMENT METHODS 0006. The tolerability and safety of two different formu IN PATIENTS WITH MUCOSITIS lations of oral transmucosal fentanyl citrate (“OTFC) were tested in cancer patients having grades 3 and 4 radiation BACKGROUND OF THE INVENTION induced oral mucositis (see Lauren Shaiova, “Tolerability 0001. Fentanyl (CAS Registry No. 437-38-7) and its salts and Effects of Two Formulations of Oral Transmucosal Fen are opioids, controlled Substances, and extremely potent nar tanyl Citrate (OTFC; ACTIQ) in Patients with Radiation cotic analgesics. Fentanyl and its citrate salt are currently Induced Oral Mucositis. Support Care Cancer (2004) marketed by a number of companies in a number of delivery 12:268-273). The study suggested that the two different fen formats. Fentanyl was introduced into medical practice in the tanyl formulations were well tolerated and that the treatments 1960s as an intravenous anesthetic under the trade name produced progressively less oral mucositis pain after admin Sublimaze. Fentanyl has an LDso of 3.1 mg/kg in rats, and istration. 0.03 mg/kg in monkeys. The LDso in humans is not known. 0007 Pain is a prevalent symptom in cancer patients, 0002 Fentanyl is also available as an injectable, a trans affecting up to 50% of patients undergoing active cancer dermal patch (such as DuragesiccR) by Janssen Pharmaceu treatment and up to 90% of those with advanced disease. In tica), and an oral lozenge on a stick (such as ACTIOR), avail these cancer populations, over half of those with chronic pain able from Cephalon, Inc.). As to the lozenge, three patents on opioid therapy will experience breakthrough pain, defined were identified in past editions of the FDA publication as a transient exacerbation of pain that occurs with otherwise Approved Drug Products With Therapeutic Equivalence stable, controlled, persistent pain. Providing pain relief from Evaluations (hereinafter “the Orange Book”) as relating to breakthrough pain is inexorably linked with the patient’s ACTIQR): U.S. Pat. Nos. 4,671,953, 4,863,737 and 5,785, immediate quality of life. And for terminal cancer patients, 989. providing pain relief may be the only thing that medical Science can offer. 0003 ACTIOR), a flavored lozenge on a stick, is swabbed 0008 Unfortunately, there is a subpopulation of patients over the mucosal surfaces inside the mouth to enable delivery in need of pain relief through opiate therapy that also suffer through the oral mucosa. ACTIOR) is indicated for opioid from a condition called mucositis. Oral mucositis is an acute, tolerant patients and is effective in treating breakthrough painful, and sometimes debilitating complication of cancer cancer pain. In clinical trials of ACTIOR), breakthrough can Surgery, chemotherapy and radiation. It occurs in 20-40% of cerpain was defined as a transient flare of moderate-to-Severe patients treated with chemotherapy alone and up to 50% of pain occurring in cancer patients experiencing persistent can patients receiving combination radiation and chemotherapy, cer pain otherwise controlled with maintenance doses of opi especially those with head and neck cancer. Mucositis occurs ate medications, including at least 60 mg of morphine?day, 50 when cancer treatments break down the rapidly divided epi ug transdermal fentanyl/hour or equal analgesic dose of thelial cells lining the gastrointestinal tract, particularly in the another opiate for a week or longer. oral cavity, leaving the mucosal tissue open to ulceration and 0004 U.S. Patent Publication Nos. 2005/0163838A1, infection. The consequences of mucositis can be mild requir 2005/0169989A1 and 2005/0142197A1, owned by CIMA ing little intervention to severe (hypovolemia, electrolyte LABS, INC., a Cephalon Company, describe effervescent abnormalities, and malnutrition) that may result in fatal com oral opiate dosage forms that include Substantially less opiate plications. by weight as compared with other known oral formulations 0009. It was believed by the inventors that patients suffer including ACTIOR. The dissolved oral opiate dosage forms ing from mild oral mucositis, generally designated as mucosi disclosed are intended for oral administration across the oral tis grade 2 or less, would require caution when dosing fenta mucosa. Products falling within the scope of at least Some of nyl transmucosally, because mucositis would affect drug these applications, and others as described herein, are cur absorption and/or flux across the oral mucosa. This could rently marketed under the trademark FENTORAR) fentanyl manifest itself in a clinically significant increase in the bio buccal tablets (“FBT). FENTORAR) is indicated for the availability of the drug, increasing the initial blood concen management of breakthrough pain in patients with cancer tration which could expose the patient to unsafe concentra who are already receiving and who are tolerant to opioid tions. As such, those patients were administrated pain therapy for their underlying persistent pain. One advantage of treatments through other methods, such as injection, increas FENTORAR), according to the prescribing information, is ing the Suffering of those already coping with unbearable that Fentora(R) has faster absorption of the API into the blood amounts of pain. stream and lower dosage levels. 0010) Ideally, every dosing option should be made avail 0005 U.S. Pat. No. 6,200,604, which issued Mar. 13, 2001 able to those patients Suffering from pain Such that they can to CIMALABS INC., a Cephalon Company, exemplifies two use which ever treatment best suits their needs. For terminal fentanyl formulations each containing 36% effervescence cancer patients, in particular, anything that can improve their and 1.57 mg offentanyl salt. See example I thereof, column 5. quality of life is highly desirable. Certainly, transmucosal line 60 through column 6, line 30. The 604 Patent describes administration would be one convenient, comfortable, and the use of amongst other things, effervescence as a penetra relatively pain-free method of administration for those with tion enhancer for influencing oral drug absorption. See also mucositis if it were possible. U.S. Pat. Nos. 6,759,059 and 6,680,071. See also Brenden berg, S., 2003 New Concepts in Administration of Drugs in SUMMARY OF THE INVENTION Tablet Form: Formulation and Evaluation of a Sublingual Tablet for Rapid Absorption, and Presentation of an Individu 0011. One aspect of the invention is a fentanyl-containing alized Dose Administration System, Acta Universitiatis dosage form designed for oral transmucosal delivery which Upsaliensis. Comprehensive Summaries of Uppsala Disser includes both an effervescent couple and a pH adjusting Sub tations from the Faculty of Pharmacy, 287, 83 pp. Uppsala stance and which can be administered to patients Suffering ISBN 91-554-5600-6. from both pain and oral mucositis. In some embodiments, the US 2011/0195996 A1 Aug. 11, 2011 size, shape, composition, and/or physical properties of the considered clinically significant. As used herein, the term dosage form can be adjusted to provide a dosage form par “uptake’ means the transfer of fentanyl across the oral ticularly well suited for patients with mild oral mucosities, mucosa, generally followed by Subsequent release into sys even when compared to other oral effervescent fentanyl for temic circulation. The inventors opined that the local tissue mulations. damage and/or the inflammation associated with mucositis 0012 Another aspect of the invention are methods of treat would offer less resistance to absorption offentanyl across ing pain comprising administering to a patient in need thereof the oral mucosa. It was believed that this lowered resistance to and who has oral mucositis, a dosage form comprising fen absorption would result in higher than expected C. Values tanyl (in free base form or a salt thereof). The dosage form is and could trigger fentanyl induced side-effects. This could designed for the administration of fentanyl across the oral necessitate reducing the dose for those having mucositis as mucosa through buccal, gingival or Sublingual administration compared with those not having mucositis. While Such a routes. The dosage form is placed in intimate contact with the change could reduce the chance and/or severity of the pos oral mucosa and retained in intimate contact with the oral sible side effects, it could also reduce the level of pain relief. mucosa, for a time sufficient to allow uptake of at least a 0020. It has been found, unexpectedly, that the condition therapeutically significant amount offentanyl across the oral of mild oral mucositis does not cause a clinically significant mucosa.
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