By Pat Anson, Editor
Titan Pharmaceuticals, Inc. (OTCC: TTNP) has announced that it received a letter from the Food and Drug Administration delaying approval for an implantable version of buprenorphine, an opioid addiction treatment drug more widely known as Suboxone.
Titan said the FDA cannot approve the application in its present form for the Probuphine implant and asked for additional information on its effectiveness.
“Titan and our partner, Braeburn Pharmaceuticals, are extremely surprised and disappointed with the FDA’s response,” said Marc Rubin, MD, executive chairman of Titan Pharmaceuticals.
“Given the nationally-recognized, growing and devastating opioid dependence epidemic, there is critical need for new safe and effective treatments that reduce the likelihood of abuse, diversion and accidental pediatric exposure, and Titan and Braeburn remain committed to making Probuphine available for patients that need it.”
Read more at National Pain Report.
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November 12, 2012
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