Titan Pharmaceuticals Inc (TTNP)

[KMBJN]

Such a great need for diversion-proof OUD treatments like probuphine.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2785011

https://www.hhs.gov/about/news/2021/04/27/hhs-releases-new-buprenorphine-practice-guidelines-expanding-access-to-treatment-for-opioid-use-disorder.html

HHS in April relaxed some of the onerous requirements for using buprenorphine for OUD, but somehow FDA really screwed Titan by making probuphine so difficult to use in practice. They massively limited which patients were eligible, made re-implantation difficult, burdened the company with post-marketing studies, etc... If they really want to expand access, what is the harm in letting everyone get the diversion proof probuphine implant as needed? Too bad Titan couldn't apply for a label expansion since there really is such a strong need to expand access to probuphine. What is easier than a quick procedure every 6 months to get a new implant?

Of course, Titan screwed it up pretty badly too. But FDA made it VERY difficult for Titan to succeed. Other, bigger pharmas seemed to have it much easier for their OUD treatments.