Mylan (NSDQ:MYL) said today that it launched its buprenorphine and naloxone sublingual film as a generic of Indivior‘s (LON:INDV) Suboxone sublingual film. The product is indicated for the treatment of opioid dependence. The therapy should be used alongside counseling and psychosocial support for people living with opioid dependence, according to Mylan. Sales for buprenorphine and naloxone […]
FDA rejects Sunovion’s NDA for Parkinson’s disease-treating apomorphine sublingual film
Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease. The Marlborough, Mass.-based company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy […]
Dr. Reddy’s notches win for generic Suboxone sublingual film
Shares in Dr. Reddy’s Laboratories (NYSE:RDY) shot up yesterday after the U.S. Court of Appeals for the Federal Circuit vacated a previous decision that blocked the company from selling a generic verson of Indivior‘s (LON:INDV) Suboxone buprenorphine and naloxone sublingual film. Dr. Reddy’s said it plans to resume launch activities for the product, which won FDA […]
AcelRx shares fall as Sen. Markey calls on FDA to reject opioid painkiller
Shares in AcelRx (NSDQ:ACRX) fell last week after U.S. Sen. Ed Markey (D-Mass) called on the FDA to reject the drugmaker’s opioid painkiller, Dsuvia. The senator noted that the product, which is designed for use in medically-supervised settings, consists of sufentanil – an opioid that is up to 10 times as powerful as fentanyl. “Even in […]
Sunovion touts pivotal Ph3 trial for Parkinson’s drug
Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations. Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that […]
Fast-dissolving opioid dependence tablet wins EU recommendation
Mundipharma International and Orexo (STO:ORX) said today that its fast-dissolving Zubsolv buprenorphine and naloxone sublingual tablet won a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The European Commission is slated to make a final decision about the product’s marketing authorization by the end of this year, the companies […]
BioDelivery Sciences beats Q2 rev estimates, misses on EPS
Shares in BioDelivery Sciences International (NSDQ:BDSI) fell today after the pharmaceutical company beat sales estimates but missed earnings expectations on Wall Street with its second quarter results. The Raleigh, N.C.-based company posted a net loss of -$14.9 million on sales of $8.7 million for the 3 months ended June 30, paring losses by 9.7% on sales […]
FDA accepts AcelRx’s NDA for Dsuvia pain reliever
AcelRx Pharmaceuticals (NSDQ:ACRX) said today that the FDA accepted the company’s New Drug Application for its Dsuvia pain relief therapy. The federal watchdog set a target decision date for October 12 this year. The company’s Dsuvia candidate is composed of 30 sufentanil tablets delivered sublingually using a disposable, pre-filled single-dose applicator to patients with moderate-to-severe […]
BioDelivery reacquires license to buprenorphine film
BioDelivery Sciences International (NSDQ:BDSI) said today that it reacquired the license to the Belbuca (buprenorphine) buccal film from Endo Pharmaceuticals. Malvern, Penn-based Endo Pharmaceuticals licensed the worldwide manufacturing and marketing rights to the opioid patch from BioDelivery in 2012. Belbuca, a once-daily opioid, is indicated for the management of severe pain. The small, peppermint-flavored film works by […]
Lupin, MonoSol Rx ink licensing deal for pediatric products
Lupin Pharmaceutical (NSE:LUPIN) said last week that it inked a licensing agreement with MonoSol Rx to develop pediatric products using MonoSol’s drug-delivery technology. Warren, N.J.-based MonoSol touts its dissolvable film, PharmaFilm, as a quick-dissolving system that’s easy to administer and masked by taste. The sublingual film is designed to support pediatric populations that often have trouble swallowing […]
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