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TTNP > SEC Filings for TTNP > Form 8-K on 23-Dec-2013All Recent SEC Filings




Other Events, Financial Statements and Exhibits

Item 8.01. Other Events.

On December 23, 2013, Titan Pharmaceuticals, Inc. (the "Company" or "Titan") announced the receipt of the official minutes (the "Minutes") from a Type C meeting with the U.S. Food and Drug Administration (the "FDA") on November 19, 2013 to discuss the Complete Response Letter (the "CRL") to its New Drug Application (the "NDA") for ProbuphineŽ, an investigational subdermal implant for the maintenance treatment of opioid dependence in adult patients.

The Minutes reflect the discussions among the FDA, the Company and its partner, Braeburn Pharmaceuticals Sprl ("Braeburn") that seeking an indication in individuals stabilized on 8 mg/day or less of sublingual buprenorphine (SL BPN) may be a suitable approval pathway for Probuphine. Titan and Braeburn proposed the revised indication following a review of the FDA's comments on the briefing material and to address one of the primary concerns in the CRL regarding dose adequacy among the original study population (newly inducted patients maintained at 12-16 mg SL BPN/day). The Minutes confirm that FDA approval of Probuphine for the revised indication will require the submission of additional clinical data in this patient population from a study it stipulated "need not be large," "be adequate and well-controlled," and "must support labeling for the duration of treatment (6 months)". Titan and Braeburn are working with experts in the field to develop a clinical study design for submission to the FDA within the next few weeks. The amended NDA will be resubmitted following completion of the clinical study and analysis of the resulting data.

A copy of the press release issued by the Company with respect to the Minutes is attached hereto as Exhibit 99.1 and is incorporated herein by reference,

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description
99.1 Press Release, dated December 23, 2013.

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