Drugs

Company Asks Court to Reverse Roxicodone Rejection

Pharmaceutical Manufacturing Research Services (PMRS) is asking the DC Court of Appeals to overturn an FDA decision refusing to approve its Roxicodone, a new opioid capsule the company says is intended to deter abuse through a novel combination of physical properties and labeling changes. The company says the Roxicodone label responded to findings from the Centers for Disease Control that FDA-approved labeling of opioids for treating chronic pain is one of the drivers of the opioid crisis. The label has a use indication for limited dosing and acute pain.

“We asked for an opportunity to address this problem with a new product and more appropriate labeling, but FDA wouldn’t even give us a hearing,” a company statement says. PMRS says FDA wouldn’t consider its new label as a means of deterring abuse and instead reviewed the drug based on the agency’s 2015 guidance framework for determining whether a drug’s physical properties alone would deter abuse by snorting or injection.

According to the company, FDA found its label language “false and misleading” because the company did not supplement its laboratory tests of a dye, an unattractive color added to the capsule to discourage occasional misuse of the product by injection, with clinical studies proving that the color would actually discourage drug abusers.

“FDA fixated on the dye we added to our formula as defining the product’s ability to deter abuse,” the company statement says. “But that makes no sense for two reasons. First, intranasal and intravenous abuse are peripheral concerns for our product, which is limited in dosing and duration. Second, the clinical studies FDA demanded are not required by the federal statute for new drug approval and have never reliably predicted real-world abuse scenarios. If FDA has a problem with specific language in our proposed label, it should modify the label, not disapprove the drug altogether.”

The PMRS court petition is here.

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