A brief review of the safety profile associated with use of saw palmetto extracts in benign prostatic hyperplasia and lower urinary tract symptoms.
Bilal Chughtai, MD: When it comes to Permixon itself, there are no contraindications for its use. I would be careful when utilizing Permixon to ensure that patients are screened and fall under the correct category. These patients should have more mild symptoms and an IPSS (International Prostatism Symptom Score) of 8 or maybe as high as 13, a Qmax (maximal flow rate) of around 15 or maybe even a little bit lower, but not a very high PVR (postvoid residual urinary volume). These are patients who are very carefully selected and can do very well with a compound like Permixon.
When we take a look at Permixon and saw palmetto, we see that there is almost no real drug-to-drug interaction. In addition, although Permixon's mechanism of action is proposed through androgen receptor signaling, it doesn't affect PSA (prostate-specific antigen) or prostate cancer screening, because it doesn't affect the PSA number. Further, when you look at adverse effect profiles, this drug has shown a very high safety profile, where the most common complaint is something like gastrointestinal upset (nausea in probably 1% of people who take it). In addition, high blood pressure is rarely reported and, even more rarely, erectile dysfunction is noted. Ultimately, when it comes to a compound that's able to preserve sexual function, minimize changes for the patient, but improve lower urinary tract symptoms (LUTS), Permixon has shown exquisite safety.
Transcript edited for clarity.