Citing Benefit Amid Epidemic, FDA Advisors Say Yes to Opioid Dependence Implant
Titan Pharmaceuticals won positive news from an FDA advisory committee Jan. 12, with panelists voting in favor of approving its implant to treat opioid addictions.
By a 12 to 5 vote, the Psychopharmacologic Drugs Advisory Committee decided that the medication’s potential to put a dent in the life-threatening epidemic — even by small and conservative amounts — was worth supporting a place in the market.
If approved, Titan’s six-month buprenorphine-containing subdermal implant Probuphine would be the first long-acting, non-oral drug of its kind to treat opioid addiction in dependent patients.
“This is an example of psychiatry breaking outside of the status quo we currently have, thinking outside the box,” said Michael Yesenko, a temporary committee voting member and patient representative.
In March 2013, the same committee voted 10 to 4, with one abstention, to recommend approval of the implant. They expressed the same concerns panel members did in the second round about the dosage level and surgical procedure required.
In 2013, the FDA sent a complete response letter to the company that, among other issues, provided recommendations on product labeling and ways to improve Titan’s proposed risk evaluation and mitigation strategy for the drug.
This time around, the company narrowed the implant’s indication and based its submission on a Phase 3 trial of 177 addicted patients. The FDA asked the committee to consider whether the company had adequately identified a patient population that could benefit from the product.
Although panel members expressed concerns about uncertainties in the data supporting its case, including missed follow-ups, they provided suggestions such as labeling for behavioral stability to encourage the treatment’s use in patients who saw the best responses.
The committee decided Probuphine showed noninferiority compared with other options. Further, its safety was well enough understood and could be monitored through REMS alongside surveillance studies and regular doctor visits.
They also called the NDA’s trial design “precedent-setting” in a difficult-to-study group and disease field, even as some urged more caution.
The news may come as a surprise for Titan. The company had received a tepid FDA response for the implant in briefing documents posted ahead of the meeting, with the agency saying the benefits do not outweigh the risks.
The FDA acknowledged that the implant has advantages over other formulations, as it is difficult to abuse and is less likely to be accidentally ingested by children. However, there are worries about implantation and removal.
The company proposed a REMS that included a training and certification program for surgical implanting, and it conducted a study that showed effects in improving some procedural errors.
Read the FDA briefing documents here: www.fdanews.com/01-11-16-fda-documents.pdf. — Victoria Pelham
Subscribe to Clinical Trials Advisor NOW and save $200 off the regular one-year price of $645 — plus receive a FREE copy of our webinar CD, Observational Studies – a $347 value!
LINKS TO KEY DOCUMENTS — Need to read regulatory references, guidances, enforcement actions, and other documents? Simply click on the source documents in your electronic issue.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing