After years of delay, partners Endo Pharmaceuticals and BioDelivery Sciences International won FDA approval for a dissolvable pain treatment, but an on-label warning of serious side effects could dull the drug's effect on the market.
Health and Human Services Secretary Sylvia Burwell announced that her department will change regulations that restrict the number of patients who can be prescribed buprenorphine, to the delight of suppliers like BioDelivery Sciences and hopefully to the benefit of the growing number of patients addicted to heroin and opioid-based prescription drugs.
BioDelivery Sciences' Onsolis, a cancer pain treatment that makes use of the company's buccal delivery platform, picked up a new FDA approval for a reformulation of the treatment, which is expected to return to the U.S. market in 2016. BioDelivery earlier this year pulled out of a commercialization partnership with Sweden's Meda, which decided to focus more on respiration, and BioDelivery is currently looking for a new partner.
BioDelivery Sciences' in-development pain gel failed to meet its main goal in a late-stage trial, a surprise turn for the company as it looked forward to an FDA submission.
Endo Pharmaceutical's investigational Belbuca buccal film strip for severe chronic pain has been accepted for review by the FDA, marking a win for the BioErodible MucoAdhesive technology to deliver drugs across mucosal surfaces like the inside of the cheek. And BEMA platform developer BioDelivery Sciences receives a $10 million milestone payment.
Squeezing it in at the end of the year, Endo Pharmaceuticals and BioDelivery Sciences filed an NDA with the FDA for the companies' buccal Buprenorphine painkiller.
BioDelivery Sciences International is partnering with Evonik to develop a formulation of buprenorphine that can be subcutaneously injected and provide continuous therapy for 30 days. BDSI will pursue an approval for opioid dependence in about three years, but also aims to develop a product for chronic pain in patients requiring continuous opioid therapy.
MonoSol Rx announced that the U.S. Patent and Trademark Office will decide by August 2015 whether BioDelivery Sciences International's BEMA drug delivery technology infringes on a patent protecting its Suboxone sublingual film.
BioDelivery Sciences International announced today that it will add about 80 patients to its Phase III pivotal trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.
More than two years ago the pain specialist Endo Pharmaceuticals stepped up with a $180 million deal to license rights to BEMA Buprenorphine, a pain therapy that had been repackaged using delivery tech from BioDelivery Sciences International, even though it had just failed the primary endpoint in a critical Phase III study. Today, Endo put out the word that its gamble had paid off, saying that a new Phase III trial hit the goal line on reduction in pain compared to a placebo, putting the treatment on a path to the FDA for a marketing decision.