Pure & Cure Gets CDSCO panel Nod To Manufacture, Market Solifenacin Succinate oral solution
New Delhi: Pure and Cure has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market Solifenacin Succinate, a competitive muscarinic receptor antagonist indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency.
This came after Pure and Cure presented the proposal for manufacturing and marketing of Solifenacin Succinate oral solution 1mg/ml along with justification for bioequivalence (BE) study and clinical trial waiver.
Solifenacin is a muscarinic antagonist with antispasmodic properties used to treat urge urinary incontinence, urgency, and urinary frequency associated with an overactive bladder.
Solifenacin is a competitive muscarinic receptor antagonist. It has the highest affinity for M3, M1, and M2 muscarinic receptors. 80% of the muscarinic receptors in the bladder are M2, while 20% are M3. Solifenacin's antagonism of the M3 receptor prevents contraction of the detrusor muscle, while antagonism of the M2 receptor may prevent contraction of smooth muscle in the bladder.
At the recent SEC meeting for Reproductive & Urology held on 20th July 2023, the expert panel reviewed the proposal presented by Pure and Cure for manufacturing and marketing of Solifenacin Succinate oral solution 1mg/ml along with justification for BE study and clinical trial waiver.
The committee noted that the Solifenacin Succinate is BCS class 1 (Biopharmaceutical classification system). The Biopharmaceutical classification system (BCS) is an advanced tool used for classifying medicines based on dissolution, water solubility, and intestinal permeability, which affect the absorption of active pharmaceutical ingredients (API) from immediate-release solid oral forms.
In accordance with the CDSCO guidelines, BE waiver can be granted for a BCS class 1 drug.
Committee also noted that Solifenacin tablets and Oro-dispersible granules are already approved by CDSCO.
After detailed deliberation, the committee recommended for grant of permission for the manufacturing and marketing of Solifenacin Succinate oral solution 1mg/ml for already approved indication.
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