Posts tagged Behshad Sheldon
Braeburn names Mike Derkacz as president, CEO

Closely held Braeburn Pharmaceuticals appointed Michael Derkacz as president and CEO, succeeding Behshad Sheldon, who is stepping down from both posts and as a director, effective immediately, but will continue to serve as a consultant to Braeburn.

Read More
Braeburn gets CMS J-code for Titan's Probuphine

Closely held Braeburn Pharmaceuticals announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) code, or permanent J-code, for Probuphine, the first and only six-month buprenorphine implant for the maintenance treatment of opioid addiction.

Read More
Titan’s Probuphine, Behshad Sheldon win Stevie awards

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant was named a gold award winner at the 13th annual Stevie Awards for Women in Business in the category of "Best New Product or Service of the Year."

Read More
Titan’s Probuphine featured at ISAM meeting

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant and marketing partner, closely-held Braeburn Pharmaceuticals, were featured in three presentations at the International Society of Addiction Medicine (ISAM) annual meeting in Montreal last week.

Probuphine, a subdermal implant of buprenorphine, is the first commercially available six-month maintenance treatment for opioid dependence. The FDA approved Probuphine in May.

Read More
JAMA article points to effectiveness of Titan’s buprenorphine implant

A randomized clinical trial reported in the current issue of the Journal of the American Medical Association found that Titan Pharmaceuticals’ (NASDAQ:TTNP) six-month buprenorphine implant, known as Probuphine, may be an effective relapse prevention treatment for stable opioid-dependent adults maintaining clinical stability with 8 mg/d or less of sublingual buprenorphine.

Read More
Braeburn provides update on training sessions for Probuphine

Healthcare provider training and certification for Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant will take place on July 15-17 in Denver by Titan’s marketing partner, closely-held Braeburn Pharmaceuticals.

The FDA cleared Probuphine in late May as the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less a day. Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America.

Read More
Buprenorphine patient limit raised to 275

The Obama Administration will raise to 275 from 100 the limit on the number of patients with opioid addiction that certain physicians can treat with buprenorphine.

The move was part of several announced by the administration as part of an effort to stem the opioid abuse epidemic that is killing nearly 80 people from overdoses every day.

Read More
Braeburn presents Probuphine data at CPDD meeting

Closely-held Braeburn Pharmaceuticals has presented data from the poster of the Phase 3 study of Probuphine, a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence, at the annual scientific meeting of The College on Problems of Drug Dependence (CPDD).

The FDA recently approved Probuphine, which was developed by its partner, Titan Pharmaceuticals (NASDAQ:TTNP), on May 26.

Read More
FDA approves Titan’s Probuphine implant for opioid dependence

The FDA has approved Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine implant, the first product for the long-term maintenance treatment of opioid dependence in clinically stable patients on 8 mg or less a day of oral buprenorphine.

“Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA commissioner Robert M. Califf, M.D. in a statement. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Read More
Knight to sublicense Titan Pharma’s Probuphine in Canada

Titan Pharmaceuticals’ (NASDAQ:TTNP) development and marketing partner, closely-held Braeburn Pharmaceuticals, and Knight Therapeutics (TSX:GUD) have entered into an agreement, giving Knight exclusive rights to commercialize Titan’s Probuphine in Canada.

Probuphine is an investigational subdermal implant designed to deliver buprenorphine continuously for six months following a single treatment, promoting patient compliance and retention, as well as helping to prevent accidental pediatric exposure.

Read More
FDA adcom votes in favor of approving Titan’s Probuphine

The Psychopharmacologic Drugs Advisory Committee of the FDA voted 12-to-5 in favor of approving Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine.

The committee’s vote followed presentation and discussion of data regarding Probuphine’s efficacy, safety, and risk-benefit profile. The FDA accepted the NDA for Probuphine last September and set an action PDUFA date for Feb. 27.

Read More