AXS-05 approved by FDA for breakthrough therapy for Alzheimer's disorder

Biopharmaceutical company Axsome recently announced that the U.SFood and Drug AdministrationAdministration(
FDA) has awarded AXS-05 breakthrough therapy for the treatment of Alzheimer's disease (AD) maniaAXS-05 is a new research NMDA receptor antagonistThere is currently no approved treatment for AD restlessnesspositive results from theCritical II/III Clinical Trials (ADVANCE-1 Study) supported the use of AXS-05 in AD agitation, which recruited 366 patients with Alzheimer's disease who were randomly classified as AXS-05, amphetamine or placebo groupThe results showed that AXS-05 could quickly improve restlessness in patients compared to placebosAt the primary endpoint, the Cohen Mansfield Excitability Questionnaire (CMAI) in the AXS-05 group decreased significantly from the baseline at week 5 (p-0.010) compared to placeboThe total CMAI scores were also better in the AXS-05 group of patients than in the amphetamine group (p 0.001)AXS-05 has good tolerance and is not associated with cognitive impairment or sedationThe most common adverse events intreatment were drowsiness (8.2 per cent in AXS-05, 4.1 per cent in amphetamines, 3.2 per cent in the placebo group), dizziness (6.3 per cent, 10.2 per cent, 3.2 per cent) and diarrhoea (4.4 per cent, 6.1 per cent and 4.4 per cent, respectively)