This came after the firm presented Phase III clinical trial report of Fesoterodine Fumarate extended-release tablets 4 mg and 8 mg before the committee.
Fesoterodine is an antimuscarinic agent used in the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Fesoterodine is used to treat bladder problems, including neurogenic detrusor overactivity and symptoms of an overactive bladder, such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate.
Fesoterodine, once converted to its active metabolite, 5-hydroxymethyltolterodine, acts as a competitive antagonist at muscarinic receptors. This results in the inhibition of bladder contraction, a decrease in detrusor pressure, and incomplete emptying of the bladder.
At the recent SEC meeting for Reproductive and Urology held on December 23rd 2022, the expert panel reviewed the Phase III clinical trial report of the anti-muscarinic agent Fesoterodine Fumarate extended-release tablets 4 mg and 8 mg presented by the drug major MSN Laboratories.
After detailed deliberation, the committee noted that;
1. Total of 216 patients were randomized into two different groups for efficacy outcomes.
2. The efficacy analysis between the two treatment groups has no statistically significant difference (p>0.05) which showed that Fesoterodine Fumarate extended-release tablets 4 mg and 8 mg and Solifenacin Succinate Tablets 5 mg and 10 mg have similar efficacy in the reduction in the mean number of micturitions, urgency episodes, urgency urinary incontinence and Night time micturitions per 24 hrs.
3. Fesoterodine Fumarate extended-release tablets 8 mg have shown a clinically meaningful reduction in a number of micturitions, urgency episodes, urgency urinary incontinence and nighttime micturitions per 24 hrs in patients who did not respond to Fesoterodine Fumarate extended-release tablets 4 mg.
4. Overall, the results of the efficacy analysis demonstrated that Fesoterodine Fumarate extended-release tablets 4 mg and 8 mg have non-inferior efficacy compared to Solifenacin Succinate Tablets 5 mg and 10 mg in the treatment of Overactive Bladder Symptoms.
5. There were no SAEs reported. All reported AE was mild-moderate in nature and similar to innovators.
In accordance with the above, the committee recommended the grant of permission to manufacture and market the drug Fesoterodine Fumarate extended-release tablets 4 mg and 8 mg.
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