Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

What I wrote...

Ms. ********,

I have been monitoring with much interest the New Drug Applications submitted by Indivior Pharmaceuticals for RPB 6000 and Braeburn Pharmaceuticals for CAM 2038. Both drugs involve depot injections of buprenorphine for the treatment of opioid addiction. As you may know, the Pyschopharmacological Advisory Committee held meetings recently for each drug, and in each case voted overwhelmingly for approval.

I am interested in the FDA's decision making process with respect to probuphine. I would appreciate being afforded a written response (or, if that's impossible access to speak with someone on the FDA staff) regarding the treatment of these NDA's vis-a-vis the treatment of the NDA of Titan Pharmaceuticals for its implantable form of buprenorphine, Probuphine. The FDA approved probuphine in 2016, requiring that patients be stablized on oral buprenrophine for six months before usage. This followed the FDA's CRL for probuphine in 2013, which was issued despite the fact an advisory committee voted in favor of approval, and probuphine demonstrated non-inferiority over sublingual buprenorphine (suboxone).

From my review of the FDA briefing materials for RPB 6000 and CAM 2038, I am not able to determine how either drug performed better than probuphine did in 2013 with "front line" addicts who had only recently begun treatment. Titan's probuphine appears to have matched the performance of RPB 6000 and CAM 2038 in Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids and the LS Means of the % Negative Urines.

For reference, please see
https://d1io3yog0oux5.cloudfront.net/_ea839ea383715833d75df26299b4b7c6/titanpharm/db/341/1103/pdf/ISAM-Probuphine.pdf)

On its face, it appears Titan Pharmaceuticals has been subjected to a double standard. The FDA's CRL nearly bankrupted the company in 2013, and had adversely affected the treatment of potentially thousands of opioid addicts who could have used probuphine over the last three years (a period where, as the FDA is aware, 170 people are dying each day from opioid addiction). I believe the public is owed a response as to the FDA's treatment of probuphine.

Your assistance would be greatly appreciated.

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