The United States Food and Drug Administration gives approval to BioDelivery Sciences' Belbuca TM (buprenorphine), an opioid treatment for chronic pain as announced by the company on Monday.
In 2012, Endo International plc licensed the rights to manufacture and market the treatment of Belbuca TM. They are expected to pay a milestone payment and royalties of $50 million to BioDelivery Sciences for the licensing agreement if it hits sales target.
Belbuca TM, a buccal film used to treat chronic pain, is intended for patients suffering from severe pain that requires continuous opioid management and to those who do not respond to other alternative treatments. It is the first buprenorphine that was developed as a film that can be dissolved when placed inside the mouth.
This allows the drug to be absorbed immediately into the bloodstream making pain relief faster administering it through other routes. The drug is projected to hit markets in 2016. It is available in seven dosages starting from 75 to 900 micrograms to allow doctors to individualize pain management through titration of dosages.
"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 L. Rauck, Director of Carolinas Pain Institute.
Chronic pain is characterized by severe pain lasting for six months or longer. It affects around 100 million Americans compared to those who suffer from diabetes (25.8 million), coronary heart disease (16.3 million) and cancer (11.9 million).
However, buprenorphine is an opioid drug that is linked with the risk of addiction. Thus, the product label of the medicine says that the physician should assess the patient's risk for addiction or abuse. Opioids are drugs used to relieve pain as they reduce its intensity the intensity of pain signals reaching the areas of the brain responsible for emotions.
Opioid use is very effective in pain management as long as it is prescribed by the doctor. However, when abused, it may lead to severe respiratory depression and death. Doctors are warned to monitor patients for risky behaviors after taking the drug.
Rajiv De Silva, president and CEO of Endo International plc reiterated that the approval of FDA for Belbuca TM 'represents a meaningful milestone for Endo Pharmaceuticals'. He added that this would bring a potent new therapy to help and support people suffering from chronic pain.
"We are proud to add Belbuca TM to our diversified portfolio of branded and generic products and we look forward to preparing for the expected U.S. launch of the drug in early 2016," he added.
Photo: Quinn Dombrowski | Flickr
