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TTNP > SEC Filings for TTNP > Form 8-K on 4-Mar-2014All Recent SEC Filings




Other Events, Financial Statements and Exhibits

Item 8.01. Other Events.

On March 3, 2014, Titan Pharmaceuticals, Inc. (the "Company" or "Titan") announced that the Company and its partner, Braeburn Pharmaceuticals, have agreed in principle with the U.S Food and Drug Administration ("FDA") on the path forward for a clinical study in support of the New Drug Application for ProbuphineŽ, Titan's investigational subdermal implant for the maintenance treatment of opioid dependence. The proposed clinical study will be a randomized, double blind and double dummy design that will provide information for a non-inferiority comparison of a six-month treatment with a dose of four Probuphine implants to treatment with 8mg or less of an approved daily dosed sublingual formulation of buprenorphine. Details of the study, including size and the data analysis plan, will be established following the FDA's review of a complete study protocol, which is expected to be submitted by Braeburn within the next two weeks

A copy of the press release issued by the Company 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 March 3, 2014.

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