Leading hair-loss treatment could be set to move to pharmacist-only category
Regulators are set to decide on a request to down-schedule a leading hair-loss treatment to the S3 (Pharmacist Only) category.
A proposal has been submitted for Finasteride (Propecia, from MSD, and its generic competitors) to be moved to S3, with the sponsor saying pharmacists were easily able to identify the need for its use, and to advise on the treatment.
The proposal will be heard at the June 2019 joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint Advisory Committee on Medicines and Chemicals Scheduling (ACCS/ACMS).
The proposal calls for an S3 entry for Finasteride “for use in males with androgenetic alopecia (male pattern hair loss) in preparations containing not more than 1 mg per dose unit in packs not greater than 30 dosage units”.
It also calls for the drug to be included in Appendix H, allowing direct to consumer advertising.
The sponsor of the proposal said the listing would provide an alternative to topical minoxidil for consumers.
“Consumers can easily identify the symptoms of male pattern hair loss and it can quite easily be verified by the pharmacist to ensure that there is no other reason for the hair loss,” they said.
“The product has been on the market for a number of years and pharmacists are well equipped to provide advice to consumers on the adverse effects, interactions and contraindications (in particular, the potential risk to the male fetus if finasteride is handled by pregnant women)”.
“The risk profile of the medicine is well defined and there are no identified drug interactions of clinical significance. There is little risk of misuse, abuse or illicit use as it does not have any effect outside of its use in hair loss or in larger doses for benign prostatic hyperplasia (BPH)”.
Submissions on the proposal must be received by the TGA by the close of business 13 May 2019.
Click here for more information on the proposal or to make a submission