Overview

Product:                        Intranasal scopolamine hydrobromide gel (“INSCOP”)

Sponsor:                       Repurposed Therapeutics, Inc. d/b/a Defender Pharmaceuticals, Inc.

Indication:                   Rapid treatment and just-in-time prevention of motion sickness (“MS”)

Regulatory Status:    505(b)(2) with Fast Track designation for military and space use

 

  • Scopolamine (USA), hyoscine (Europe) is a tropane alkaloid drug with muscarinic antagonist effects.

  • Scopolamine exerts its effects by acting as a competitive antagonist at muscarinic acetylcholine receptors

  • Used by Great Britain in chemical defense in the place of atropine

  • Historically, scopolamine has been administered orally, subcutaneously, ophthalmically , intramuscular, intravenously and by transdermal patch

  • Most routes limited by side effects, onset of efficacy and/or half-life issues

  • With a precise dosage, INSCOP gel formulation has been shown to work faster and more reliably than other routes with few if any side effects

Regulatory/INSCOP History

  • In 2012, Epiomed Therapeutics, Inc. acquired the Investigational New Drug Application (NDA) for intranasal scopolamine hydrobromide gel (INSCOP) from NASA through a Space Act Agreement after NASA’s prior partner, Nastech, had ceased its development support, and subsequently Epiomed signed a CRADA with the US Navy in 2013 for the development of INSCOP  

  • In 2014, Repurposed Therapeutics, Inc. (“RTI”) acquired Epiomed with the goal of completing the NDA process for INSCOP gel. RTI continues to work closely with the US Navy and NASA on this project. 

  • In March 2016, RTI received Fast-Track designation from the FDA.

Competition:              None; alternatives have slow onset and/or users suffer from somnolence

 

Insufficient Alternatives:

Currently the most effective medication for the prevention of motion sickness is scopolamine as a prescription product.  Commercially-available scopolamine products include injectable and transdermal products. These formulations are limited by their requirement for parental injection for the former, and for the latter slow therapeutic onset and side effects which are unacceptable in operational personnel in critical military situations and space missions.  Alternatives are oral medications that are also characterized by slow onset and unfavorable side effects, which include OTC oral medications such as dimenhydrinate, diphenhydramine, and meclizine, as well as prescription medications such as promethazine.

Clinical and
Medical Uses of Scopolamine
for Military,
First-Responders and Civilians

  • Motion & Space Sickness

  • Depression

  • Post-Traumatic Stress Disorder

  • Traumatic Brain Injury

  • Chemical Defense

  • Post-operative nausea and vomiting

  • Gastrointestinal spasms

  • Renal or biliary spasms

  • Aid in GI radioloty and endoscopy

  • Irritable bowel syndrome

© 2019 Repurposed Therapeutics, Inc.