Med Check: Sleep Apnea App, Tavapadon for Parkinson’s, DEA Okays Increased Vyvanse Production, and more

In September, the U.S. Food and Drug Administration (FDA) cleared for marketing Apple Inc.’s Sleep Apnea Notification Feature, the agency announced. The feature is an over-the-counter software-only mobile medical application included in Apple’s Health App. The feature analyzes Apple Watch sensor data to identify patterns of breathing disturbances that could indicate moderate to severe sleep apnea and provides a notification to users age 18 years or older who have not previously received a sleep apnea diagnosis.

The FDA noted that the feature is not intended to diagnose, treat, or aid in the management of sleep apnea, adding that the absence of a notification is not intended to indicate the absence of sleep apnea.

Patients with Parkinson’s disease who took the dopamine D1/D5 receptor partial agonist tavapadon in the Phase 3 TEMPO-1 trial experienced improvement in dyskinesia, Abbvie announced in September.

In the trial, 529 patients ages 40 to 80 years old with early Parkinson’s disease took either 5mg or 15mg of tavadapon or placebo once per day for 26 weeks. At study’s end, patients who took 5mg or 15mg had a 9.7-point or a 10.2-point improvement, respectively, in their scores on the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III combined score, compared with a 1.8-point deterioration among patients who took placebo.

Those who took either dose of tavapadon also had improvement in motor aspects of experiences of daily living as measured by the MDS-UPDRS Part II, compared with those who took placebo.

These findings build on the Phase 3 TEMPO-3 trial, in which patients who took tavapadon alongside levodopa experienced more time without troublesome dyskinesia than those who took placebo.

Axsome Therapeutics announced in September that the FDA has accepted the company’s resubmission of a New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. AXS-07 is a combination medication that includes 20mg of the nonsteroidal anti-inflammatory drug meloxicam and 10mg of the headache drug rizatriptan.

In May 2022, the FDA issued a Complete Response Letter to Axsome regarding the company’s original NDA, stating that the agency could not approve the drug because it needed additional data pertaining to the product’s chemistry and manufacturing process. The FDA did not request any additional safety or efficacy data beyond what had been established with the INTERCEPT and MOMENTUM Phase 3 trials. In both trials, significantly more patients who received a single dose of AXS-07 reported being free from migraine pain and/or free of their most bothersome symptom (such as nausea or sensitivity to light) two hours after dosing, compared with those who took placebo.

In September, the U.S. Drug Enforcement Administration (DEA) gave approval for Takeda Pharmaceuticals to increase its production limit of Vyvanse (lisdexamfetamine) by 24%. The approval comes after a request by the FDA in July advising the DEA that a “shortage of an active ingredient” is the reason for the ongoing shortage of all marketed generic lisdexamfetamine dimesylate capsules and chewable tablets. The FDA’s letter requested that the DEA increase the aggregate production quotas (APQ) and individual manufacturing quotas for lisdexamfetamine to a level that the FDA deems necessary to address the shortage.

“After considering these factors, DEA determined that it is necessary to increase the established 2024 APQ for the Schedule II controlled substances lisdexamfetamine and d-amphetamine (for conversion) to be manufactured in the United States to provide for the estimated needs of the United States and export requirements to meet domestic and global demand,” the DEA wrote. D-amphetamine, another Schedule II controlled substance, is used by some manufacturers as part of the synthesis pathway to manufacture lisdexamfetamine products.

Big Health announced in September that the FDA has granted clearance for DaylightRx, a prescription device that delivers cognitive behavioral therapy (CBT) as an adjunct to usual care in the treatment of generalized anxiety disorder in patients 22 years old or older. The device, which must be ordered by a licensed health care professional, is intended to improve symptoms of generalized anxiety disorder.

The approval was based in part on a clinical trial in which 256 patients with moderate to severe anxiety were randomized to either treatment using the app or a waitlist control group for six weeks. At follow-up four weeks after the intervention ended, 71% of patients who used DaylightRx experienced remission of their anxiety symptoms, compared with 33% of those in the waitlist group. Patients who used DaylightRx also reported significant improvements in overall mood and sleep.

In its announcement, Big Health said that the device teaches patients evidence-based techniques to change the thoughts and behaviors that maintain chronic worry and anxiety. DaylightRx is a 90-day treatment.■