August 29, 2014 5:05 PM ET

Pharmaceuticals

Company Overview of Braeburn Pharmaceuticals, Inc.

Company Overview

Braeburn Pharmaceuticals, Inc. develops and commercializes medical products. It develops Probuphine for the treatment of adult patients with opioid dependence. The company was founded in 2012 and is based in New York, New York.

New York, NY 

United States

Founded in 2012

Phone:

609-751-5375

Key Executives for Braeburn Pharmaceuticals, Inc.

President and Chief Operating Officer
Global Head of Quality Assurance and Quality Control
Age: 57
Head of Research and Development
Age: 60
Executive Vice President of Clinical and Regulatory Affairs
Head of Commercialization for Apple Tree Partners and Partner of Apple Tree Partners
Age: 54
Compensation as of Fiscal Year 2014.

Braeburn Pharmaceuticals, Inc. Key Developments

Braeburn Pharmaceuticals, Inc. Enrolls First Patients in Late-Stage Clinical Study of Probuphine(R) for Opioid Dependence

Braeburn Pharmaceuticals, Inc. announced that the first patients have been enrolled in its Phase 3 clinical study of Probuphine(R), a subdermal implant for the maintenance treatment of opioid dependence. The trial is designed to address questions the agency posed in its complete response letter last year, after its review of the original New Drug Application (NDA). Completion of the Braeburn Phase 3 study is expected by the middle of 2015, to be followed by resubmission of the NDA later in the year. Fourteen sites are actively screening patients for randomization into the study, and five patients have already been enrolled. The clinical study is a randomized, double-blind, double-dummy design that is expected to enroll approximately 180 patients into two parallel treatment arms. The study population consists of clinically stable patients who are receiving maintenance treatment with an FDA-approved sublingual formulation containing buprenorphine at a daily dose of 8 mg or less. Patients are being randomized to receive either four Probuphine implants, or to continue daily sublingual buprenorphine therapy. 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 arms.

Titan Pharmaceuticals Inc. Announces and Braeburn Pharmaceuticals Agreement in Principle on Path Forward for Probuphine Clinical Study with the U.S. Food and Drug Administration

Titan Pharmaceuticals Inc. announced that the company and its partner, Braeburn Pharmaceuticals, have agreed in principle with the U.S. Food and Drug Administration (FDA) on the design of a clinical study in support of the New Drug Application (NDA) for Probuphine(R), the company'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 Braeburn expects to submit within the next two weeks.

Braeburn Pharmaceuticals, Inc. Appoints Frank E. Young as Executive Vice President, Clinical and Regulatory Affairs

Braeburn Pharmaceuticals, Inc. announced that former FDA Commissioner Frank E. Young, M.D., Ph.D., has joined the management team as Executive Vice President, Clinical and Regulatory Affairs. If approved, Braeburn's first product will be Probuphine(R), a buprenorphine implant for the maintenance treatment of opioid addiction, currently under review at the U.S. Food and Drug Administration (FDA). Braeburn has licensed rights from Titan Pharmaceuticals, Inc. to commercialize Probuphine in the U.S. and Canada. Dr. Young served as Commissioner of the U.S. Food and Drug Administration from 1984 to 1989 during the Reagan and Bush administrations.

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