BioDelivery Sciences International Inc said the U.S. Food and Drug Administration had approved its opioid treatment for chronic pain, sending the drugmaker’s shares up 19 percent in premarket trading on Monday.
Endo International Plc licensed the worldwide manufacturing and marketing rights to the treatment, Belbuca, from BioDelivery in 2012.
Belbuca is an opioid film patch and aims to treat patients with chronic pain who need round-the-clock treatment and for whom current alternatives do not suffice.
The film patch is placed on the inner lining of the cheek, leading to faster delivery of analgesic drug buprenorphine directly into the blood stream.
The abuse of opioids, a class of drugs that include heroin and prescription painkillers, has long been a concern in the United States. An overdose of prescription painkillers can produce euphoric highs and even disrupt parts of the brain that control breathing.
Buprenorphine has a lower abuse potential than most opioid medications. The Belbuca treatment can also prevent misuse through snorting or injecting as the film patch is difficult to crush or liquefy.
The approval comes a little more than a month after the FDA staff flagged dosage concerns over Collegium Pharmaceutical Inc’s opioid drug, Xtampza, and Purdue Pharma’s fast-acting oxycodone painkiller.
BioDelivery’s shares, which closed at $5.28 on Friday on the Nasdaq, were at $6.25 before the bell.
(Reporting By Samantha Kareen Nair and Amrutha Penumudi in Bengaluru; Editing by Maju Samuel)
Source: Reuters Health