The drug used for the treatment of opioid addiction – buprenorphine, commonly known as Suboxone – had been sold exclusively by Reckitt-Benckiser, a British pharmaceutical company, until its patent ran out in 2012. Since then, several pharmaceutical companies have rushed into the growing market to treat opioid addiction.
Braeburn Pharmaceuticals and Titan Pharmaceuticals (NASDAQ: TTNP) are joining the mix, as they jointly announced today that the Food and Drug Administration (FDA) Advisory Committee will review its new drug, Probuphine, on January 12, 2016.
Probuphine is an investigational implant that gives patients a steady dose of buprenorphine, an opioid addiction treatment drug, for up to 6 months via tiny rods about the size of a matchstick, which are implanted under the skin in the upper arm. It is intended to promote patient compliance as compared to oral formulations of buprenorphine sold under the brand name Suboxone.
“The data from the final phase 3 trial, which was designed in collaboration with the FDA in response to questions raised in the complete response letter, is compelling and we look forward to presenting it on January 12,” said Braeburn Pharmaceuticals President and CEO Behshad Sheldon. “More long-term treatments are needed to help people stay in recovery, and we remain excited about the potential for Probuphine to be the first of many new options for people with opioid addiction.”
Titan was told to conduct more research by the FDA in April 2013, when the agency surprisingly denied approval of the implant after FDA advisory committee had voted 10 to 4 a month earlier in favor of Probuphine. At that time, the FDA staff questioned the effectiveness of the implant and suggested the dose was too low, noting in clinical trials that about half of the patients treated with Probuphine required additional doses of Suboxone to treat their withdrawal symptoms.
The companies hope to enter the buprenorphine opioid addiction market, which racked up $1.75 billion in sales in the U.S. just last year.
“The Braeburn team has been interacting closely with the FDA, and we continue to support them as the Probuphine New Drug Application (NDA) advances,” said Titan Pharmaceuticals President Sunil Bhonsle. “We look forward to a successful meeting.”
You can find other National Pain Report articles related to buprenorphine here.