DPI-386 FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 31, 2024.
FDA Approved: No
Brand name: DPI-386
Generic name: scopolamine
Dosage form: Nasal Gel
Company: Defender Pharmaceuticals, Inc.
Treatment for: Motion Sickness
DPI-386 (scopolamine) is an intranasal gel formulation of the approved anticholinergic agent scopolamine in development for the prevention of nausea and vomiting associated with motion sickness.
- Motion sickness can occur in individuals while engaging in leisure or travel related activities involving most forms of travel, including flying, boating/fishing, car, bus, and train. It is a common and transient response to an unfamiliar or unnatural motion or contradictory spatial sensory information. Symptoms include pallor, cold sweating, nausea, and vomiting.
- Motion sickness symptoms can also have a detrimental impact on the ability of various military personnel and astronauts to perform assigned duties, potentially impacting readiness and negatively impacting resources.
- Scopolamine is a well established medication for the treatment or prevention of motion sickness, and was first approved as a transdermal patch formulation over forty years ago.
- Scopolamine is thought to act in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center. Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function.
- The intranasal gel formulation of scopolamine demonstrated rapid absorption in pharmacokinetic studies. Potential benefits include ease of use and rapid onset of action.
- The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DPI-386. Priority review status has been granted for the NDA at the request of the U.S. Navy, and the Prescription Drug User Fee Act (PDUFA) action date for the decision on the submission was set for January 26, 2024. On January 30, 2024, it was announced that the FDA had issued a Complete Response Letter (CRL) in response to the NDA, and that Defender Pharmaceuticals will schedule a formal meeting with the FDA to fully understand the issues raised in the CRL.
Development timeline for DPI-386
Further information
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