1-While doctors do have flexibility to prescribe off label in the US the drug will have some sort of REMS making off label use unlikely.
2-I'm not into tanning but consider the delivery method do you think a lot of people will want a subcutaneous implant not to mention some AE's that go along with Scenesse for a tan?
3-There is the issue of COGS (not sure on what it is for Scenesse) too so they couldn't make the price too low.
IMO the best opportunity in tanning would be some OTC topical form of afamelanotide or some derivative molecule.
I don't think Scenesse is happening for Vitiligo either that's just my opinion based on a few things (poor trial, limited efficacy, company delaying development). Again I think a different molecule would be better suited for this indication.
That being said I really like Scenesse for EPP and other Orphan indications just wish the company was more competent at developing in these indications not to mention dealing with regulators and payers.
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