OtiTopic Moves towards Its Clinical Phase with Dry Powder Inhalation of Aspirin to Reduce the Risk of Vascular Mortality in Patients with Suspected Acute Myocardial Infarction (Ml)

OTITOPIC™ is an early stage pharmaceutical, privately funded drug development company with a track record of success in Pharmaceutical product drug delivery and drug device development. ASPRIHALE™ is a proprietary Dry Powder Inhalation of aspirin formulation delivered via portable dry powder inhaler (DPI) that is expected to enter the bloodstream faster than oral tablets at the time of MI. OTITOPIC™ is on track with ASPRIHALE™ to file an NDA for a novel drug-device combination product in rescue management of suspected acute myocardial infarction (MI). OTITOPIC™ is committed to providing high-risk MI patients with a faster alternative for management of suspected myocardial infarction (MI).

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FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor’s office or clinic

The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).

“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment. Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.”

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