Finasteride

Medicine Compliance Aid Stability · New Medicines ·

109035006

Medicine Compliance Aid Stability

Proscar · Merck Sharp & Dohme Ltd

Merck Sharp & Dohme Ltd
Proscar
Tablets 5mg
R2 · Red 2 · Drug is not suitable for CAs due to theoretical reasons that cannot be mitigated.
Unsuitable
Store in the original package. Crushed or broken tablets should not be handled by pregnant women or women of child-bearing potential. Protect from light. Store in airtight containers.
19th February 2015

Propecia · Merck Sharp & Dohme Ltd

Merck Sharp & Dohme Ltd
Propecia
Tablet f/c 1mg
A3 · Amber 3 · No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Airtight container
Protect from light
Protect from light. Store in airtight container.
24th September 2015

New Medicines

Alopecia in men

Information

New formulation
Polichem
Polichem

Development and Regulatory status

None
Phase III Clinical Trials
None

Mar 18: Polichem (a subsidiary of Almirall) has completed a randomised, double-blind PIII trial (EudraCT2015-002877-40; NCT03004469), which evaluated the safety and efficacy of topical finasteride in the treatment of males with androgeneic alopecia (n=459). Results are awaited [3].


Nov 16: Almirall is planning to conduct a pre-IND meeting with the US FDA Q4 2016 [2].

Category

Topical solution formulation of finasteride (0.25%), a cholestenone 5α reductase inhibitor
Androgenetic alopecia is a characteristic pattern of balding in men, which becomes more common with age. There may be bitemporal recession and/or a central recession to produce a characteristic horseshoe shape of remaining hair. Half of men are affected by the age of 50 [1].
Alopecia in men
Topical

Trial or other data

May 16: PIII trial to evaluate safety and efficacy of finasteride topical solution for treatment of male patients with androgeneic alopecia (EudraCT2015-002877-40). The randomised, double-blind trial expects to enrol approximately 450 patients in Hungary and Spain [2].


Mar 14: PII study to assess the dose response, pharmacodynamics and pharmacokinetics of finasteride topical solution, after 7 days of treatment in men with androgenetic alopecia starts (PM1332). The trial will investigate four dosages in 32 subjects in Switzerland [2].