JUPW - Jupiter Wellness inks exclusive licensing deal with Rejoy for new prescription products

• Jupiter Wellness ( NASDAQ: JUPW ) said Tuesday it signed an exclusive licensing deal with Rejoy to develop prescription products to treat nipple neuropathies in breast cancer patients.
• The license includes issued patents and technology, including formulations.
• In clinical studies, one topical formulation improved nipple sensitivity, alleviated associated sexual problems, increased female sexual lubrication and improved overall orgasmic response.
• JUPW plans to file for a pre-IND meeting with the U.S. FDA within the next 12 months for the product, named JW-500, and will seek Orphan Drug Designation.
• Since the current formulation contains an approved drug, expedited 505 (b)(2) regulatory pathway is expected.
• 505 (b)(2) allows for FDA approval without having to complete all the steps typically required for new drug applications.

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