A drug approved to treat depression has shown promise for easing Alzheimer’s disease-related agitation in a late-stage clinical trial.
Positive results in a stage 2 / 3 clinical trial found that Axsome’s AXS-05 drug prevented and delayed recurrent agitation symptoms, BioPharmaDive has reported.
AXS-05 is a pill that contains two drugs, including bupropion, a depression medication, and was approved by the Food and Drug Administration in August to treat major depressive disorder. It is sold under the brand name Auvelity.
In the initial portion of the agitation study, participants who took the drug had a more than threefold lower risk of recurrence when compared with placebo. During a double-blind portion of the study, the agitation relapse rate was 7.5% when compared with approximately 26% in the control group, according to BioPharmaDive.
Approximately 70% of people with Alzheimer’s disease experience agitation, the news outlet noted. Agitation may include aggression, irritability and emotional distress.
Alzheimer’s drug death raises concerns
The news comes as a second death has been reported in a late-stage trial of another Alzheimer’s drug hopeful.
The anti-amyloid drug lecanemab, developed to target and reduce Alzheimer’s-associated brain plaques, has shown positive results in people with early disease. Those who took the lecanemab treatment saw a 27% reduction in cognitive and functional decline compared with those in the placebo group, drugmakers Eisai and Biogen announced in September.
The findings were touted by the Alzheimer’s Association as the “most encouraging” to date of a treatment that targets an underlying cause of the disease. And the planned unveiling of the full data on Tuesday, Nov. 29, has been eagerly awaited by patient advocates who are pushing for more treatments after several anti-amyloid drugs failed to meet clinical trial targets. But the new death, after a patient experienced a stroke, is the second linked to hemorrhage, or bleeding in the brain, during the lecanemab trials.
Bleeding issues
A physician who performed an autopsy on the deceased patient has said that he attributes the death to lecanemab, according to a report by FierceBiotech. The drugmakers, meanwhile, have stated that “all the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause,” the news outlet reported.
Brain hemorrhage also is a concern when using aducanumab (Aduhelm), the first drug approved to treat Alzheimer’s by targeting anti-amyloid brain plaques. Use of the drug requires regular brain scans to watch for signs of bleeding or swelling in the brain. The Centers for Medicare & Medicaid Services has restricted drug’s use to clinical trials only.
Correction: The date of the planned data release by Biogen and Eisai was Tuesday, Nov. 29, not Wednesday, Nov. 30, as initially reported.
