Novel Binge Eating Disorder Treatment Accepted for Review by FDA
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline (Sunovion) in the treatment of binge eating disorder.
All articles by Steve Duffy
FDA Cracks Down on Company Selling CBD Products With Unapproved Therapeutic Claims
The Food and Drug Administration (FDA) has issued a warning letter to Curalef Inc. of Wakefield, Massachusetts for illegally selling unapproved cannabidiol (CBD) products online with unsubstantiated health claims.
Despite Warnings, Companies Continue to Sell Kratom With Unproven Claims
Two companies have been issued warning letters by the Food and Drug Administration (FDA) for illegally selling unapproved, misbranded kratom-containing drug products.
Jornay PM, an ADHD Med Dosed in the Evening, Now Available
The treatment utilizes a proprietary drug delivery platform which consists of 2 functional film coatings: the first layer delays the initial drug release for up to 10 hours and the second layer helps control the release rate of the active ingredient throughout the day.
Review Describes Dangers Associated With Loperamide Abuse
A recent review published in The Journal of Clinical Pharmacology discusses the antidiarrheal medication loperamide and its potential for abuse in patients looking to self-treat opioid withdrawal symptoms or to experience euphoric effects with large doses.
Suvorexant Evaluated for Insomnia in Patients With Alzheimer Disease Dementia
Results from a study evaluating the safety and efficacy of suvorexant (Merck) for the treatment of insomnia in patients with mild to moderate Alzheimer disease dementia were presented at the AAN meeting.
FDA: Boxed Warning, Contraindication Added to Several Insomnia Medications
A new Boxed Warning will be required in the prescribing information for several insomnia medications following reports of serious injuries and deaths associated with complex sleep behaviors where patients engaged in activities while not fully awake.
Microbiota Transfer Therapy Gets Fast-Tracked for ASD Treatment
The FDA has granted Fast Track status to the microbiota transfer therapy, Full-Spectrum Microbiota (FSM), for the treatment of children with autism spectrum disorder.
Prebiotics and Probiotics Evaluated for Depression, Anxiety Treatment
According to the results of a random-effects meta-analysis, there is a small, but significant, amount of evidence that supports the use of probiotics in the treatment of depression and anxiety.
First Prescription Device Approved to Treat ADHD
The FDA has permitted for marketing the first medical device indicated for the treatment of attention deficit hyperactivity disorder ADHD.
