PHARMACY

Amneal, Actavis settle generic Rytary litigation

BY David Salazar

Amneal Pharmaceuticals and Actavis recently settled litigation over Actavis’ generic of Rytary, a Parkinson’s disease treatment from Impax, now Amneal’s specialty pharma division. The litigation had been pending in a New Jersey District Court since Actavis filed an Abbreviated New Drug Application for a generic of the product.

Under the settlement, Ameal will grant Actavis a license to sell its generic Rytary on July 31, 2025, or earlier under certain circumstances. The launch is contingent on Food and Drug Administration approval of Actavis’ generic. The companies did not disclose additional details about the settlement.

“We are pleased to have settled the outstanding litigation with Actavis regarding Rytary,” Amneal president and CEO Rob Stewart said “We will continue to defend our existing patents and explore opportunities to further expand our intellectual property portfolio around Rytary.”

Amneal still has separate litigation pending with both Sandoz and Zydus Pharmaceuticals about both companies’ proposed Rytary generics.

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FDA clears CBD-based epilepsy drug Epidiolex

BY David Salazar

The Food and Drug Administration has approved a new epilepsy treatment, marking the first approval of a drug whose active ingredient is a purified drug substance derived from marijuana. Epidiolex (cannabidiol, or CBD, oral solution) is indicated to treat two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients 2 years old and older.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA commissioner Scott Gottlieb said. “And, the FDA is committed to this kind of careful scientific research and drug development. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.

CBD is not the primary psychoactive component of marijuana, the FDA said. Gottlieb noted that the agency would continue to support research on potential medical uses of marijuana-derived products while combatting illegal marketing of CBD products with unproven medical claims. “Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases,” he said.

For the patients whose seizures are treated by Epidiolex — developed by U.K.-based GW Pharmaceuticals — the drug has potential to impact their lives, according to FDA officials.

“The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients’ quality of life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition.”

Epidiolex will be marketed by Greenwich Biosciences, GW Pharmaceuticals’ U.S. subsidiary. Before being made available for patients, the drug has to be rescheduled from its current Schedule I status, which the company anticipates in the next 90 days, with the company projecting a Fall availability.

“These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care,” GW CEO Justin Grover said.

 

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House passes opioid bills package

BY David Salazar

The House of Representatives recently passed a legislative package that included the Every Prescription Conveyed Securely Act. The passage of the National Association of Chain Drug Stores-backed mandate for electronic prescribing of controlled substances under Medicare Part D joins various other components of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act.

“There is no silver bullet to remedy the opioid epidemic, but the EPCS Act is one of many pieces of opioid legislation that helps curb the causes of the crisis impacting our families, friends and communities,” the bill’s lead sponsor, Rep. Markwayne Mullin, said. Rep. Katherine Clark, who introduced the bill, said that the legislation would make it harder for prescription forgery to occur and make tracking prescriptions easier.

A January Morning Consult Poll commissioned by NACDS found that 76% of respondents supported rules that require all prescriptions to be handled electronically. NACDS has made e-prescribing a key component of its public policy recommendations for curbing opioid abuse, which also includes compliance programs, drug disposal, increased naloxone access and stopping online drug-sellers, among others.

“NACDS is grateful to Reps. Katherine Clark and Markwayne Mullin for spearheading and championing this important legislation, and we also extend gratitude to House Energy and Commerce Committee Chairman Greg Walden and Ranking Member Frank Pallone, Jr., for their proactive, effective work in advancing a bill that will be part of a solution to a difficult but extremely critical issue,” said NACDS President and CEO Steve Anderson.

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