Corium (NSDQ:CORI) today announced clinical data demonstrating the strong performance of its once-daily ADHD capsule. Boston-based Corium’s Azstarys oral capsule for treating ADHD symptoms (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) received FDA approval in March as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients […]
Neurological
FDA to make decision on Corium’s transdermal patch for treating dementia next year
Corium (NSDQ:CORI) announced today that the FDA set a Prescription Drug User Fee (PDUFA) target action date for its Adlarity system. The FDA set the PDUFA target action date for Adlarity (donepezil transdermal system), a transdermal patch designed to treat dementia or Alzheimer’s disease, for March 11, 2022. If approved, Boston-based Corium’s once-weekly Adlarity patch […]
European regulators offer positive opinion on Janssen’s schizophrenia treatment
Johnson & Johnson’s Janssen Pharmaceutical Companies today announced a positive CHMP opinion on its Byannli schizophrenia treatment. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion. The committee recommended using long-acting atypical antipsychotic Byannli (6-monthly paliperidone palmitate; PP6M) therapy for the maintenance treatment of schizophrenia. […]
Pear Therapeutics touts real-world data for reSET-O prescription digital therapeutic
Pear Therapeutics today announced the publication of positive results from real-world data of its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics evaluated its FDA-authorized reSET-O PDT in the treatment of opioid use disorder (OUD) on patients treated for 24 weeks, with real-world evidence demonstrating that the treatment is associated with improved outcomes, high levels of […]
Impel NeuroPharma prices $45M offering following FDA approval for migraine treatment
Impel NeuroPharma (NSDQ:IMPL) announced that it priced an underwritten public offering of common stock worth $45 million. The offering includes 3 million shares of common stock priced to the public at $15 per share, with gross proceeds set to total $45 million before deducting underwriting discounts and commissions and other offering expenses payable by Impel […]
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after […]
Bexson Biomedical aims to extend its wearable drug delivery device to psychoactive drugs
Bexson Biomedical announced today that it launched an R&D initiative to develop subcutaneous formulations of psychoactive therapeutics. Santa Barbara, Calif.-based Bexson’s effort will apply its existing subcutaneous formulation technology to build several psychoactive drug scaffolds for treating mental health indications, including post-traumatic stress disorder (PTSD) and depression. Formulations developed through the R&D initiative are designed […]
Satsuma launches Phase 3 trial for acute migraine combination product
Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine. STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have […]
FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy
Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN. Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication […]
Pear Therapeutics touts 9-month data for reSET-O
Pear Therapeutics today touted results from an extended retrospective analysis of real-world data for its reSET-O prescription digital therapeutic. Boston-based Pear Therapeutics developed its reSET-O prescription digital therapeutic (PDT) for treating opioid use disorder (OUD). According to a news release, results from the nine-month real-world data analysis demonstrated a continued long-term reduction in costly healthcare […]
