Request to Foster a Transition to Abuse-Deterrent Opioids and Promoting Greater Access to Treatment for Opioid Addiction and, More Specifically, Medication-Assisted Treatment ("Mat"), as set out in the Petition-CLOSED
cder 2013-4480 medication-assisted treatment abuse-deterrent opioids ANDA abuse abstinence Epidemic Prescription Pills CDC closed
2013-08-15
FDA-2013-P-0703-0003
04:00:00
https://api.regulations.gov/v4/comments/FDA-2013-P-0703-0003
Anonymous
Anonymous
I am very disturbed by a recent FDA decision to fail to approve Titan Pharmaceuticals new drug application for Probuphine, a novel implant to aid those who are addicted to opioids in eliminating their dependency and resuming normal and productive lives. With the current epidemic of opioid addiction in the United States and the current emphasis placed on finding ways to combat this addiction while reducing the extreme risk of diversion of these medications, this medication can be pivotal in the process of change.  Probuphine met the criteria for approval which the FDA themselves established for the drug to meet- the ADCOM on March 21st rendered a positive vote of 10 members For Approval, 4 Against, with 1 Abstaining- yet the drug was not approved by the FDA on April 30th. The reasons for non-approval make little to no sense, given what the FDA agreed to at the outset of Titans study in order for approval. Everything the FDA was asking for in their Complete Response Letter to Titan Pharmaceuticals could have been determined post-approval, and Titan could have proceeded forward in changing and saving peoples lives immediately. The decision on April 30th by the FDA would suggest something more than mere trepidation on their part. This is a huge step backwards in President Obamas pledge to combat and eradicate this scourge on the American people. I would urge the FDA to look into this matter at their earliest possible convenience. A delay of 6-30 months to gain approval on this drug could cost the lives of many more people who might otherwise be saved here and now by its approval. The opioid addiction epidemic has been well-documented and has become a focus of the current administration- right here, right now is a viable answer and alternative to what is woefully, inadequately available currently.