Chronic pain drug Belbuca from Endo Pharmaceuticals gets approval from FDA

media@latinoshealth.com By Mai Peralta Oct 27, 2015 06:00 AM EDT

The US Food and Drug Administration have approved Belbuca, a chronic pain drug from Endo Pharmaceuticals.

Endo Pharmaceuticals is a subsidiary of Endo International PLC and BioDelivery Sciences International, Inc. (BDSI). Their drug Belbuca (buprenorphine bucca) has been approved by the Food and Drug Administration (FDA) today. The drug can be prescribed for patients suffering from severe chronic pain that needs round-the-clock, long-term pain management treatment.

Street Insider reports that it is the only buprenorphine medication designed to come in a film that can be absorbed through the cheek.

"Belbuca is uniquely formulated with our BEMA® drug delivery technology that allows for high bioavailability of buprenorphine in the bloodstream, and represents an important new option for patients and healthcare providers," said Dr. Mark Sirgo, CEO and President of BDSI, in a statement.

Belbuca will be available in early 2016 and will come in different dosage strengths ranging from 75 micrograms to 900 micrograms every 12 hours.

"The availability of new, convenient and flexible treatment options is important for patients whose lives are burdened by chronic pain, a debilitating condition that affects more Americans than diabetes, heart disease and cancer combined," said Dr. Richard Rauck from Carolinas Pain Institute, in a statement.

"BELBUCATM provides a unique approach for chronic pain management, combining the proven efficacy and established safety of buprenorphine with a novel buccal film delivery system that adds convenience and flexibility. For both opioid-naive and opioid-experienced patients who require around-the-clock treatment and for whom alternative treatment options are inadequate, BELBUCATM offers appropriate, consistent pain relief and a low incidence of typical opioid-like side effects."

The approval of the Belbuca was based on two randomized trials in patients with chronic low back pain. According to Drug Discovery & Development, the trials were done in patients who have tried opioids and those who have not. They were given the study drug or placebo and researchers found that Belbuca helped improved pain relief in patients who have received it. However, side effects of the drug were reported including dry mouth, dizziness, headache, vomiting, nausea, constipation, fatigue, diarrhea, somnolence and upper respiratory tract infection.

Reuters reports that because buprenorphine has lower instances for opioid abuse, it can be prescribed to patients for six months. The film with which the medication comes with will be difficult to snort, inject, crush or liquefy, lowering the possibilities of misuse and abuse as it goes directly to the blood stream instead of the digestive tract via the inner lining of the cheek. Additionally, it can also decrease constipation as a drug side effect.

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