Med Check

FDA Fast Tracks Alzheimer’s Medication

Alzheon Inc.’s oral anti-amyloid medication ALZ-801, a prodrug formulation of the compound tramiprosate, has been granted fast-track status by the Food and Drug Administration (FDA).

Tramiprosate—which was designed to break down amyloid aggregates—failed in a previous clinical trial, but investigators found data to suggest the prodrug version could work in patients with the APOE4 risk gene.

Alzheon is initiating a new phase 3 study of ALZ-801 that will specifically enroll participants who are homozygous for the risk gene and have a diagnosis of mild Alzheimer’s.

FDA Committees Recommend Approval of Buprenorphine Injectable

The FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee jointly voted 17-3 in favor of approving of CAM2038, a buprenorphine injection for the treatment of adults with opioid use disorder (OUD).

CAM2038, developed by Braeburn Pharmaceuticals, is available in both weekly and monthly formulations. The drug is intended to be administered by health care professionals to ensure proper delivery of medication, while also minimizing risks of diversion, misuse, and accidental pediatric exposure.

The committee’s recommendation was based on the results of seven clinical trials, including a phase 3 efficacy study and a long-term safety study. CAM2038 was given a priority review designation by the FDA in September.

FDA Approves Implant For Sleep Apnea

The FDA in October approved an implantable neurostimulation device to treat moderate-to-severe central sleep apnea.

Central sleep apnea occurs when the brain fails to send signals to the diaphragm to breathe. The resulting loss of sleep quality can lead to a range of physical and behavioral complications. 

The device, called the Remedē System, is an implanted nerve stimulator that sends electrical currents to the phrenic nerve to stimulate the diaphragm and restore normal breathing. The Remedē System, manufactured by Respicardia, is implanted under the skin of the upper chest. 

The approval was based on a clinical trial of 141 patients. After six months, more than half of the patients implanted with the active Remedē System saw at least a 50 percent reduction in their apnea hypopnea index, which measures the severity and frequency of sleep apnea, compared with only 11 percent of patients in the control group.

Alkermes Submits NDA For Long-Acting Injectable Initiator

Alkermes has submitted a New Drug Application to the FDA for its novel injectable compound Aripiprazole Lauroxil NanoCrystal Dispersion. The product was designed to provide extended-release aripiprazole in a formulation that enables faster dissolution and leads to more rapid achievement of therapeutic levels of aripiprazole.

If approved, administration of this product in conjunction with a single oral dose of 30 mg aripiprazole could replace the need for three weeks of concominant oral aripiprazole following the first injection of the extended-release formulation of aripiprazole, according to the company.

“Patients with schizophrenia are particularly vulnerable to nonadherence and relapse when transitioning from inpatient care to outpatient settings,” said Alkermes’ Executive Vice President of Research and Development Elliot Ehrich, M.D., in a press release. “The ability to initiate long-acting treatment with Aristada on Day 1 without the need to continue oral supplementation during this critical transition period may be a useful and welcomed option for the clinical community.” ■