Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

505(b)(2)

It's a beautiful thing when it works. With probuphine, the FDA got fussy about the implant being used for an opioid, and required six phase III's, so basically there was no benefit in 505(b)(2) being used on probuphine.

But take a look at Braeburn's risperidone implant. One small Phase I, and then a Phase III for efficacy and a safety Phase III (each of which involved only 50 participants). They will file the NDA by year end.

In an email exchange with an analyst, I learned that it's likely that Titan will be able to skip Phase II for ropinirole. If it can get two small trials approved by the FDA for Phase III, then the implant could be a reality sooner than we think.

July 2017 Commence Phase I (3 month study with 10-15 patients)
November 2017 Phase I results
March 2018 Commence two Phase 2/3's (3 month study with 100 total patients)
August 2018 Phase III Results
December 2018 File NDA




http://www.prnewswire.com/news-releases/braeburn-pharmaceuticals-achieves-primary-endpoint-in-pivotal-phase-23-study-of-bb0817-risperidone-6-month-implant-for-treatment-of-schizophrenia-300446397.html