“The top-line Phase III results for ALM12845 (androgenic alopecia) in the EU show statistical significance for the primary end-point (Change of Target Area Hair Count) at week 24. We expect the submission in Europe of ALM12845 in Q4 2019.”
My guess is that a “submission” in Europe means the same as in the US: i.e., the company is filing for approval to sell the new drug after successful Phase 3 trial completion.
April 19, 2019
Polichem — Topical Finasteride Phase 3 Trial Results
Earlier today, Switzerland-based Polichem (now owned by Spain’s Almirall) finally released the results of its Phase 3 trials for its eagerly awaited P-3074 topical finasteride product. This came after many months of anticipation.
Edit: It seems like they released results in the EU last month, in a slightly different format to the US ones from today. I never wrote about this important development last month.
From what I can tell, both oral finasteride (105 test patients) and topical finasteride (48 test patients) seem to have given almost the same results in increase in hair growth after 24 weeks.
Side effects between oral and topical finasteride also seem similar, although they are based on surveys of the patients rather than any scientific methodology.
I suppose many volunteers would drop out if they were asked to come in every couple of months for testing of erectile strength, hormonal blood tests, sperm count and so on. As it is, even in these trials, around 30 percent of subjects dropped out before the 24 weeks were over.
Most studies from the past several decades suggest very limited potential for long-term side effects from oral finasteride. If you do not believe those studies, you could still try out topical finasteride (available at most local compounding pharmacies).