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BioDelivery Sciences Opioid Gets FDA Approval for Chronic Pain

Xconomy Raleigh-Durham — 

BioDelivery Sciences International has received FDA approval for a chronic pain treatment that uses the company’s proprietary drug-delivery technology.

With the regulatory nod, Raleigh, NC-based BioDelivery (NASDAQ: BDSI) is now in line for a $50 million milestone payment from Endo Pharmaceuticals, the unit of Endo International (NASDAQ: ENDP) that licensed the treatment in 2012.

The BioDelivery product, called Belbuca, is not actually a new drug. The treatment administers an old drug, the painkiller buprenorphine, through a thin, dissolvable film placed on the inside of the cheek. That drug delivery technology was developed to more quickly and efficiently administer medication into the bloodstream, and it has been a platform for earlier BioDelivery products treating breakthrough cancer pain and opioid addiction.

The FDA approved Belbuca to manage chronic pain that doesn’t respond to other pain drugs and is severe enough to require daily, all-day treatment. But buprenorphine is an opioid, which comes with the risk of addiction. Because of those risks, the BioDelivery product’s label warns doctors assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing the treatment, and to monitor patients for these behaviors afterward. Opioids can also slow down breathing down to dangerously low levels, risking death. The drug’s label says these risks are greatest when starting the drug, or after a dose increase. Doctors are warned to monitor patients for respiratory effects. But the BioDelivery opioid treatment is expected to reduce the risk of abuse compared to other opioids available in pill form, which can be crushed and snorted.

BioDelivery says it expects Belbuca will become commercially available in the first quarter of 2016; the company stands to gain additional milestone payments and royalties from Endo if the drug hits sales targets. With the $50 million milestone payment, BioDelivery says it expects to have enough cash to carry the company through mid-2017.

Photo courtesy of Flickr user Joel Kramer under a Creative Commons license.