Drugs

Intellipharmaceutics Working to Remedy FDA Rexista Concerns

Reacting to significant adverse votes from members of two FDA advisory panels against its Rexista abuse-deterrent oxycodone formulation, executives of Canada’s Intellipharmaceutics say they will try to remedy the concerns raised by the panel members by completing human abuse potential studies in relation to the intranasal and oral routes of abuse. The executives say the company will continue to work with FDA in the next few weeks as the 9/25 PDUFA date approaches.

Rexista is intended to be a unique abuse-deterrent generic form of Purdue Pharma’s OxyContin. Its most notable feature is that it contains a blue dye that is emitted if a tablet is manipulated, which reportedly could help identify abusers, and a nasal irritant aimed at discouraging misuse.

Members of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 22-1 that Rexista should not be approved at this time. They also voted 19-4 that the company failed to demonstrate that the drug has properties that can be expected to deter abuse by the intravenous route of administration, and 23-0 that there were insufficient data to support labeling language about abuse-deterrent properties for the intravenous route of administration.

Panel members generally echoed concerns raised by FDA medical reviewers before the joint meeting. They noted that the company did not conduct any safety studies on the blue dye and raised questions about the ingredient’s potential toxicity and whether the bright color would attract addicts rather than deter them.

“I can see Smurf parties and blue lollipops suddenly becoming popular,” commented U.S. Substance Abuse and Mental Health Services Administration senior medical advisor Melinda Campopiano.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome