This is a perfect example of how unbelievably negligent the FDA is and also a chance to spread awareness about PFS. On December 13, 2021 the FDA approved this new drug called ENTADFI, which is a combination of tadalafil and Finasteride. Tadalafil is a generic PDE5 inhibitor used for erectile dysfunction, similar to Viagra, and it is also approved for the treatment of benign prostatic hyperplasia (BPH). The company behind ENTADFI, Veru, claims that this drug has fewer sexual side effects than previous treatments for BPH. In the clinical trials, they only compare ENTADFI to finasteride alone. They fail to compare it to tadalafil alone. The package insert fails to warn about the serious possibility of permanent side effects.
How is this any different than just taking a cheap generic drug to try to counteract the erectile dysfunction caused by finasteride? Actually, if patients want a more effective treatment of BPH with fewer sexual side effects, they should just take tadalafil alone. The biological mechanism through which finasteride causes sexual dysfunction almost certainly isn’t by constricting the blood vessels that PDE5 inhibitors dilate.
I guess that Veru isn’t afraid of lawsuits from patients who develop PFS, if they’re bringing a new finasteride product to the market. I wonder how it will be priced compared to these two generic medications. It’s almost certainly a price gouging scheme because they need to recoup the money spent on clinical trials and marketing this new drug.
This company was founded by urologists. They put ENTADFI under their Sexual Health Division. Are the doctors and scientists involved in bringing this drug to market really not aware of Post-Finasteride Syndrome? Are they not aware how dangerous finasteride is compared to tadalafil? Do they really think that this drug will improve people’s lives or do they just view it as a scam to make money? Is this entire company a scam? I’m just as mystified by what the scientists at the FDA who approved this were thinking. In Vertu’s press release they basically say that they’re going to market it directly to instead of trying to convince doctors: “ENTADFI will be marketed and distributed by Veru’s own direct to patient telemedicine and telepharmacy services platform”.
People in the Post-Finasteride Syndrome and Post-SSRI Sexual Dysfunction communities need to take action to warn the public about this scam. I already wrote emails to Dr. David Healy and Public Citizen, the organization that is legally representing the Post-Finasteride Syndrome Foundation in their lawsuit against the FDA for failure to respond to the Citizen Petition. Maybe other people can contact doctors and politicians who are knowledgeable about PFS. We could also reach out to the investment community, since Veru is a publicly traded on the NASDAQ with the stock ticker of VERU. Could also try complaining to the FDA to amend the warnings in the package, although they probably won’t change it.
See link to Veru press release and FDA package insert for ENTADFI below:
Veru Announces FDA Approval of ENTADFI, a New Treatment for Benign Prostatic Hyperplasia
Entadfi Approved for Benign Prostatic Hyperplasia