Med Check: Caplyta; FDA, and DEA Warning; Aduhelm; and More

The Food and Drug Administration (FDA) approved two additional dosage strengths of the atypical antipsychotic Caplyta (lumateperone) for two specific patient populations, Intra-Cellular Therapies announced in April. The two populations affected are patients who take CYP3A4 inhibitors and patients with moderate (Child-Pugh class B) and severe (Child-Pugh class C) liver impairment. Caplyta is approved for the treatment of adults with schizophrenia and depressive episodes associated with bipolar I or II disorder as monotherapy and as adjunctive therapy with lithium or valproate.

The new recommended dosage for patients who take strong CYP3A4 inhibitors is 10.5 mg once daily, and the new recommended dosage for patients who take moderate CYP3A4 inhibitors is 21 mg once daily. These dosages are a reduction from the previous dosages because taking CYP3A4 inhibitors increases exposure to lumateperone.

The new recommended dosage for patients with moderate or severe liver impairment is 21 mg once daily. This dosage is a reduction from the previous dosage because patients with impaired liver function were found to have higher exposure to lumateperone than patients with normal liver function.

The new dosage strengths are expected to be available in pharmacies later this year.

 

In April the FDA and the Drug Enforcement Administration (DEA) issued joint warning letters to two online pharmacies, kubapharm.com and premiumlightssupplier.com for illegally selling Schedule II stimulants, including amphetamine drug products marketed as Adderall (amphetamine/dextroamphetamine). These websites sell Adderall online without a prescription.

In a statement, the FDA said that people should dispose of unused medicine from these websites and not purchase or use prescription drugs sold from these websites without a prescription.

“Illegally marketed prescription drugs pose significant risks to consumers who purchase those products. Consumers who buy prescription drugs from unsafe online pharmacies may put their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise harmful,” the agencies wrote.

 

The Centers for Medicare & Medicaid Services (CMS) in April released a national policy for coverage of Biogen’s Alzheimer’s medication Aduhelm (aducanumab) and any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease. The guidance restricts reimbursement for Aduhelm only if it is used in a clinical trial.

Aduhelm was approved last year to treat Alzheimer’s disease via the FDA’s accelerated approval pathway, which is designed to speed up the approval of medications for serious or life-threatening illnesses by allowing companies to provide a surrogate endpoint that reasonably predicts future clinical benefit.  The surrogate endpoint for Aduhelm was evidence that people who took the medication had significantly greater reduction of amyloid beta plaques in their brains after 78 weeks than those who took placebo. These plaques are a hallmark of Alzheimer’s disease.

 

The FDA is seeking comments through June 21 on a proposed mail-back envelope requirement that would provide patients who receive opioids on an outpatient basis with an option to mail back their unused medications and with education on the safe disposal of opioid medications. If implemented, this proposal would be incorporated into the existing Opioid Analgesic Risk Evaluation and Mitigation Strategy.

“Such a requirement could reduce the amount of unused opioid analgesics in patients’ homes, thereby reducing opportunities for nonmedical use, accidental exposure, and overdose, and possibly reducing the development of new opioid addiction,” the agency wrote in an article “Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting; Establishment of a Public Docket; Request for Comments” in the Federal Register. ■