Alkermes Comes Under FDA Scrutiny for Vivitrol Ad Omitting Serious Warnings
While claims about the benefits of Vivitrol were clearly presented in the ad, serious risks, such as vulnerability to opioid overdose, were not communicated.
All articles by Diana Ernst, RPh
Psilocybin Designated as Breakthrough Therapy for Depression
The FDA has granted Breakthrough Therapy designation to psilocybin for the treatment of major depressive disorder.
Pimavanserin Improves Negative Symptoms of Schizophrenia in Trial
Currently, there is no FDA-approved therapy to treat the negative symptoms of schizophrenia.
New Drug Application for Olanzapine/Samidorphan in Schizophrenia, Bipolar I Disorder
The application includes data from the ENLIGHTEN-1 and ENLIGHTEN-2 studies, in which treatment with the combination therapy was compared with placebo or olanzapine monotherapy in patients with schizophrenia.
Stellate Ganglion Block Treatment Evaluated for PTSD
Among patients who received stellate ganglion block (n=74), the adjusted mean CAP-5 total symptom severity score change from baseline was -12.6 points (95% CI, -15.5, -9.7 points) vs -6.1 points (95% CI, -9.8, -2.3 points) for those who received sham treatment.
Food for Thought: Mood Improvements Following Dietary Modification
A recent report published in the journal Neuropsychobiology describes the case of a 34-year-old woman with major depressive disorder whose symptoms improved following the initiation of an elimination diet.
Potential First-in-Class Treatment for Tourette Syndrome Gets Fast Track Status
The Food and Drug Administration (FDA) has granted Fast Track designation to ecopipam (Emalex Biosciences), an investigational agent for the treatment of Tourette syndrome (TS).
OTC Gel Helps Patients Who Have Trouble Swallowing Medications
Phazix, a gel designed to help patients who have difficulty swallowing medications, has been made available over-the-counter by Arkray USA.
FDA Rejects sNDA for Hetlioz in Jet Lag Disorder
The FDA has rejected the supplemental New Drug Application for Hetlioz (tasimelteon; Vanda Pharmaceuticals) for the treatment of jet lag disorder.
Do US Adults Use More Prescription Drugs Than Canadians?
Prescription drug use appears to be similar in the US and Canada, according to a new data brief from the Centers for Disease Control and Prevention (CDC).
- Loading...
Loading...
Next post in Practice Management
Loading... 
Loading...