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Re: turks post# 4823

Thursday, 04/23/2015 1:13:01 PM

Thursday, April 23, 2015 1:13:01 PM

Post# of 16886
On April1, 2015, Kate Glassman-Beebe - EVP and Chief Development Officer Of Titan Pharmaceuticals stated during the conference call:

Just to remind everybody, the Probuphine study is a randomized, double-blind, double-dummy designed that enrolled 178 patients into two parallel treatment arms across 20 clinical centers. Study participants are clinically stable patients who receive maintenance treatment with an improved sublingual formulation containing Buprenorphine at a daily dose of 8 milligrams or less.

Patients have been randomized to receive either four Probuphine implants or to continue their daily sublingual Buprenorphine therapy.

Now to enable the double blind design, those receiving Probuphine implants are required to take daily placebo sublingual pills, while those continuing on their stable dose of sublingual Buprenorphine pills are required to be treated with four placebo implants. The patients are expected to be treated for six months and the primary analysis will be a non-inferiority comparison of responders in the two treatment arms.

Responder status will be based on an FDA agreed upon clinical algorithm, and as based on urine testing for opioid use, together with patient self-reported opioid use. We believe this study design is robust and will provide a well-controlled evaluation of Probuphine compared with the current standard of care in these stable maintenance patients.

Now off note, all participants are receiving active treatment during the study. We continue to support Braeburn in all study related efforts and are encouraged by the progress to date.

As previously mentioned, we expect study results in late second quarter of this year and we're looking forward to assisting Braeburn in the re-submission of the NDA in the second half of this year with the potential for product approval in the first half of 2016.






Take Care and God Bless....God Bless Us All.





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