Titan Pharmaceuticals Inc (TTNP)

[Doctor Detroit]

Braeburn's Ad Comm on injectables is tommorrow. Haven't had a chance to fully review the FDA briefing memo, but it's pretty interesting they didn't submit a REMS and the FDA is asking for one...I wonder if that will be a cause for a delay in approval.

31% drop out rate in the study, which shows how difficult it is to keep addicts in treatment. 90% of probuphine patients from Q2 had their treatment continued, although granted they are all patients who had been stablized on bupe. Still, with the high drop out rate, I would be interested to know if the injectables are that much more successful than sublingual. From the study...


The number of patients and healthy volunteers exposed to CAM2038 and discontinued from any study in the clinical development program was 226 (31.0%). However, the number of participants who were reported as discontinued to an AE in the clinical development program was low [12 (1.6%) out of the 729 exposures]. Other listed reasons for discontinuation included physician decision (n=13), lack of efficacy (n=12), lost to follow-up (n=45), withdrawal by subject (n=87), and other (n=11). The AEs leading to discontinuation are currently under review.




https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM582592.pdf