MedCheck; Psilocybin, Roluperidone, Latozinemab, Lacosamide
Psilocybin Promising for Anxiety Disorder
Incannex’s investigational psilocybin product PSX-001 appeared to be effective in relieving symptoms of generalized anxiety disorder in a phase 2 clinical trial, the company announced in February.
In the PsiGAD1 trial, 72 patients with generalized anxiety disorder were randomized> to receive psychotherapy with either psilocybin or placebo for seven weeks. Their symptoms were measured with the Hamilton Anxiety Rating Scale (HAM-A) at baseline and at 11 weeks.
The reduction in HAM-A score from baseline in the psilocybin group was 12.8 points, compared with a reduction of 3.6 points in the placebo group. In addition, 44% of patients in the psilocybin group showed a clinically meaningful improvement (at least a 50% reduction in anxiety scores from baseline), which was more than four times higher than that of the placebo group. Further, 27% of patients in the psilocybin group achieved full disease remission, a rate more than five times higher than that of the placebo group.
FDA Rejects Roluperidone for Negative Symptoms of Schizophrenia
In February the Food and Drug Administration (FDA) rejected the New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia, Minerva Neurosciences announced.
In its Complete Response Letter, the FDA cited several clinical deficiencies:
Although one study (MIN-101C03) demonstrated statistical improvements in negative symptoms, it is insufficient on its own to establish substantial evidence of effectiveness.
The NDA submission also did not establish that the change in negative symptoms with roluperidone treatment was clinically meaningful.
The NDA submission lacked data on concomitant antipsychotic administration.
The safety data did not include enough patients exposed to roluperidone at the proposed 64 mg dose for at least 12 months.
The FDA’s letter stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms of schizophrenia. The letter added that Minerva must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.
Latozinemab Gets Breakthrough Status for Frontotemporal Dementia
The FDA granted Breakthrough Therapy designation to latozinemab for frontotemporal dementia with a progranulin gene mutation, Alector Inc. announced in February. Progranulin regulates immune activity in the brain and helps keep neurons and other brain cells healthy.
A Breakthrough Therapy designation expedites the development and review of drugs for serious conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing options on at least one clinically significant endpoint.
The FDA granted Breakthrough Therapy designation for latozinemab based on the results of the phase 2 clinical trial INFRONT-2. This trial evaluated 12 patients with a progranulin mutation causative of frontotemporal dementia who were treated with 60 mg/kg of latozinemab every four weeks over 12 months. The study found that treatment with latozinemab in these patients slowed disease progression by about 47% over one year compared with a control group of frontotemporal dementia patients. The study also found that latozinemab elevated progranulin in both plasma and cerebrospinal fluid in the patients for the duration of treatment.
Motpoly XR Now Available For Treatment of Partial-Onset Seizures
In February Aucta Pharmaceuticals Inc. announced its launch of Motpoly XR (lacosamide) extended-release capsules C-V in the 100 mg, 150 mg, and 200 mg doses for the treatment of partial-onset seizures in adults and in pediatric patients who weigh at least 50 kg (110.2) pounds. Motopoly XR is bioequivalent to Vimpat (lacosamide) film-coated tablets C-V and provides a once-daily option at equivalent doses. It will be available through retail pharmacies.
The prescribing information for Motopoly XR notes that prescribers should monitor patients for suicidal behavior and ideation. It also notes that the drug may cause dizziness, ataxia, and fainting. In addition, it recommends that prescribers obtain an electrocardiogram before beginning the medication and after titration to steady-state maintenance and to closely monitor patients with underlying proarrhythmic conditions or on concomitant medications that affect cardiac conduction. Finally, Motopoly XR should be gradually withdrawn to minimize the potential of increased seizure frequency. ■
