Med Check: Clonazepam Recall, Lumateperone and Schizophrenia Relapse, and More
Endo Expands Voluntary Recall of Clonazepam
In November, Endo Inc. announced that it was expanding its voluntary recall of clonazepam orally disintegrating tablets because a limited number of cartons may have been printed with the incorrect strength and National Drug Code by a third-party packager. However, the blister strips and tablets inside the product pack reflect the correct strength for the lot.
The following lots have been voluntarily recalled:
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Clonazepam ODT, USP (C-IV) 2mg; NDC# 49884-310-02; Lot# 550176501, 550176601
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Clonazepam ODT, USP (C-IV) 0.125mg; NDC# 49884-306-02; Lot# 550174101
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Clonazepam ODT, USP (C-IV) 0.25mg; NDC# 49884-307-02; Lot# 550142801, 550142901, 550143001, 550143101, 550143201, 550143301, 550143401, 550147201, 550147401
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Clonazepam ODT, USP (C-IV) 1mg; NDC# 49884-309-02; Lot# 550145201, 550175901, 550176001, 550176201
Experimental Alzheimer’s Treatment Simufilam Fails Phase 3 Trial
Simulfilam, an experimental oral drug for the treatment of Alzheimer’s disease, did not meet the primary endpoints of a Phase 3 trial, Cassava Sciences announced in November. Simufilam is an oral small-molecule drug that targets the filamin A protein, which is thought to contribute to amyloid-beta and tau protein pathology and thus contribute to the progression of Alzheimer’s disease.
In the ReThink-ALZ trial, 804 patients with mild to moderate Alzheimer’s were randomized to take either 100 mg of simufilam or placebo twice per day for 52 weeks. The co-primary endpoints were the change in cognition and function from baseline to the end of the double-blind treatment period at week 52, assessed by the Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-COG12) and the Alzheimer Disease Cooperative Study-Activities of Daily Living Score (ADCS-ADL).
At week 52, those in the simufilam group had about a 2.8-point average increase on the ADAS-COG12 from baseline, compared with 3.2 points in the placebo group. Those in the simufilam group also had about a 3.3-point decline on the ADCS-ADL (indicating more functional impairment) from baseline, compared with a 3.8-point decline in the placebo group. Neither result was statistically significant.
Lumateperone May Prevent Relapse in Patients With Schizophrenia
Patients with schizophrenia who took Caplyta (lumateperone) as a maintenance treatment had fewer relapses than those who took placebo, Intra-Cellular Therapies announced in November.
In a Phase 3 trial, 228 adults took 42 mg of lumateperone each day for 18 weeks. They then were randomized to either continue taking lumateperone or be switched to placebo for up to 26 weeks or until they had a relapse, whichever came first. There were 18 relapses in the lumateperone group compared with 44 relapses in the placebo group, meaning that lumateperone reduced the risk of relapse 63%.
Lumateperone was generally well tolerated in this study. The most common treatment-related adverse event (observed at least twice as much in the active versus placebo group) in the maintenance phase was headache.
Psilocin Promising for Treating Depression in Phase 2 Trial
A small Phase 2 trial of the psilocybin analog CYB003 (psilocin) suggests that it may be helpful as an adjunct for treating patients with major depressive disorder, Cybin announced in November.
The trial included 34 patients who received two doses of either 12 mg or 16 mg of CYB003, spaced three weeks apart. Participants continued taking their existing antidepressants and received facilitative psychotherapy known as EMBARK.
Seven participants in the 16-mg group and 10 in the 12-mg group reached the 12-month follow-up. Among participants who took two doses of 16-mg CYB003, Montgomery-Åsberg Depression Rating Scale (MADRS) scores dropped an average of 23 points at 12 months, while among participants who took two doses of 12-mg CYB003, MADRS scores dropped an average of 18 points. No new adverse events were reported in the 12-month follow-up, including no reports of suicidality.
In March 2024, the U.S. Food and Drug Administration granted Breakthrough Therapy designation for CYB003 based on four-month data from the trial. Breakthrough Therapy designation expedites the development and review of drugs for serious conditions.In its announcement, Cybin stated that it has initiated a Phase 3 trial, PARADIGM, to evaluate CYB003’s efficacy and safety in a larger population with major depressive disorder. ■
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Psychiatric News
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Published online: 24 December 2024
Published in print: January 1, 2025 – January 31, 2025
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