Neurelis Inc. announced the commercial availability of Valtoco (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in adult and pediatric patients 6 years of age and older.
The collaboration will utilize EVERSANA’s integrated suite of outsourced services to commercialize and distribute Evoke Pharma Inc.’s Gimoti in the United States.
UCB announced that the U.S. Food and Drug Administration approved a New Drug Application for the company’s anti-epileptic drug Nayzilam (midazolam) nasal spray CIV.
When major depressive disorder does not respond to at least two different types of antidepressant treatments in a moderate-to-severe depressive episode, it’s reclassified as treatment-resistant depression (TRD). South San Francisco-based VistaGen Therapeutics’ AV-101 failed to meet the primary efficacy endpoints for TRD in a Phase II clinical trial.
Generic drugmaker Teva Pharmaceutical Industries Ltd. received approval from the U.S. Food and Drug Administration to market the company’ generic nasal spray for opioid overdose.
Allergan Plc’s experimental add-on treatment for depression failed three late-stage studies, casting doubts over the company’s drug pipeline and sending the Botox maker’s shares down nearly 4 percent.
Johnson & Johnson said the company’s new nasal spray depression treatment Spravato will be priced at $590 for a 56-milligram dose and $885 for an 84-milligram dosage.
The U.S. FDA approved Johnson & Johnson’s nasal spray antidepressant Spravato for people resistant to other treatments, but placed restrictions on use of the drug.
Shares of Opiant Pharmaceuticals fell in trading after the company announced that the Phase II trial evaluating a naloxone nasal spray for the treatment of bulimia nervosa failed to meet primary endpoints and will discontinue the program.
A U.S. FDA advisory panel voted in favor of J&J’s experimental nasal spray esketamine, which has a compound similar to often-abused ketamine, bringing the drug closer to approval.