Industry Briefs

FDA Approves New Once-Daily ADHD Medication That Lasts Up to 16 Hours

The FDA has approved Mydayis—a long-acting amphetamine manufactured by Shire Plc.—for the treatment of attention-deficit/hyperactivity disorder (ADHD) in individuals aged 13 and up.

Mydayis contains the same active ingredient as Shire’s Adderall (the enantiomers levoamphetamine and dextroamphetamine) but is encapsulated by three types of drug-releasing beads to provide more sustained release up to 16 hours. Currently, extended-release Adderall lasts up to 12 hours.

The FDA approved Mydayis on the basis of 16 clinical studies encompassing more than 1,600 adults and adolescents with ADHD, according to a press release by Shire. In placebo-controlled studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD Rating Scale-IV and the Permanent Product Measure of Performance. The most common side effects among both adolescents and adults were insomnia, decreased appetite, and decreased weight.

Shire said it expects that Mydayis will be commercially available in the United States in the third quarter of 2017.

FDA to Release REMS Plan for Prescribers of Immediate-Release Opioids

In remarks delivered before the FDA Scientific Meeting on Opioids in July, FDA Commissioner Scott Gottlieb announced that the FDA’s risk-management requirements that apply to extended-release opioid formulas will be extended to include immediate-release opioid drugs.

The FDA’s Risk Evaluation and Mitigation Strategy (REMS) requires companies that manufacture opioids to educate prescribers on issues such as assessing patients’ pain, managing opioid use, and recognizing addiction when it arises.

“This regulatory tool is needed to ensure that the benefits of how these drugs are prescribed continue to outweigh the risks of misuse, abuse, addiction, overdose, and death,” Gottlieb said.

As part of the new requirements for immediate-release opioids, manufacturers must also include information on rival nonopioid pain therapies and nonpharmacological approaches to pain relief.

Commissioner Gottlieb stated that opioid manufacturers will get details on next steps soon. “[R]elevant letters, detailing the new requirements, will be sent to IR [immediate-release] manufacturers in the coming weeks,” he said. ■