12 Apr 2-week Gemtesa Samples for OAB now available at Sansum Urology
Gemtesa is a recently approved beta agonist medication for the treatment of OAB which includes symptoms of urinary urge incontinence, urgency and frequency. The medication is taken daily by mouth with or without food and is crushable. Unique to this OAB medication the side effect profile is minimal which is important given the need for chronic long-term use to control OAB. The previously utilized beta agonist Mirabegron sometimes caused increased blood pressure and headaches which narrowed its use. The 75 mg daily dose works within 2 weeks unlike Mirabegron which took 4 weeks with the higher 50 mg dose. The medication is highly selective to the beta-3 adrenergic receptor on the bladder which both expedites time to effectiveness and reduces adverse side effects to negligible amounts. The drug increases bladder capacity which calms the detrusor bladder muscle during filling.
The 12-week EMPOWUR trial demonstrated a very clean safety profile (<2% stopped use due to side effects) coupled with meaningful efficacy. Although the response was comparable to Detrol (Anticholinergic), given its tolerability perhaps increased adherence over time might be achieved if affordable. Patients taking DIGOXIN require additional steps to ensure minimal drug interactions. 52% of trial participants with urinary urge incontinence (UUI) had a 75% reduction in UUI episodes vs placebo (~37%). 43% of trial participants had a 50% reduction in urgency episodes vs placebo (`38%).
Unfortunately, many patients who respond to safer OAB medications can only afford traditional Anticholinergics with recent increasing concern about prolonged use anticholinergic use and link to dementia. Patients with both a meaningful and tolerable response to a 2-week sample of GEMTESA will be prescribed the medication for daily use. With the use of a coupon (PPO commercial insurance plans) cost may be greatly reduced with the initial drug launch. Government plans (Medicare and Medicaid) and HMO insured patients often need to endure a prior authorization process which might not be successful to achieve an acceptable price. We will make every effort to provide this new safer medication at a reasonable price if able when effective for patients. Otherwise consideration to PTNS, Botox and SNM should be considered as described below.
We look forward to witnessing& tracking Gemtesa’s real-life use given the tremendous need for better OAB therapy options. Below is the most updated OAB care pathway framing the future role of GEMTESA.