- The USPTO issues a Notice of Allowance to Palatin Technologies (NYSE:PTN -4.3%) for its Patent Application No. 14/313,258 covering methods of treating female sexual dysfunction utilizing the formulation and dose of bremelanotide used in its ongoing Phase 3 studies and commercialization, once approved. When issued, the patent should be effective until November 2033.
- Top-line results from the Phase 3s are expected in Q3. If successful, a New Drug Application (NDA) will be filed in H1 2017.
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Bremelanotide is a synthetic peptide analog of the naturally occurring hormone alpha-MSH, a melanocortin agonist. The melanocortin system plays a key role in sexual function as well as pigmentation, inflammation and energy homeostasis. Its value proposition versus Valeant Pharmaceuticals' (VRX +0.6%) Addyi (flibanserin) is the avoidance of hypotension and syncope (temporary loss of consciousness) when combined with alcohol.
- In an earlier study, the most common bremelanotide-related adverse events were facial flushing, nausea and headache.