Studies In clinical studies, the topical formulation improved nipple sensitivity and alleviated associated sexual problems. Concomitantly, the formulation was also shown to increase female sexual lubrication and improve overall orgasmic response.
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JW-500 is pre-revenue.
Next Steps We plan to file for a pre-IND meeting with the US FDA within the next 12 months and intend to seek Orphan Drug Designation. An expedited 505 (b)(2) regulatory pathway for development is anticipated as the current formulation contains an already approved drug.
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