Glenmark gets CDSCO Panel nod to Study FDC Of Bilastine, Dextromethorphan ,Phenylephrine Syrup
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to drug major Glenmark to conduct the pharmacokinetic (PK) study of the pulmonary fixed dose combination drug Bilastine 3.3 mg plus Dextromethorphan Hydrobromide 10 mg plus Phenylephrine Hydrochloride 5 mg syrup.
This came after the drug major Glenmark Pharmaceuticals presented the PK study protocol of the pulmonary FDC Bilastine plus Dextromethorphan Hydrobromide plus Phenylephrine Hydrochloride Syrup before the committee.
Earlier, the Medical Dialogues Team had reported that, in response to the Phase III clinical trial protocol presented by the drug major Glenmark and its proposal for a bioequivalence (BE) study waiver, the Central Drug Standard Control Organization (CDSCO) panel had opined the firm to justify the dose of bilastine in the proposed FDC for further review by the committee.
Bilastine is an anti-histamine which is used to treat allergies. It works by blocking the effects of a chemical messenger known as "histamine," which is naturally involved in allergic reactions. In short, it helps to relieve the discomfort and unpleasant symptoms that occurred due to allergic conditions, like blocked/runny/itchy nose, red/watery eyes, and skin rashes.
Dextromethorphan Hydrobromide is an anti-tussive (relieve cough) medication primarily used to treat dry cough. It works by blocking the cough receptor present in the brain, which is known to cause cough.
Phenylephrine is an alpha-1 adrenergic agonist that mediates vasoconstriction1 and mydriasis depending on the route and location of administration. Systemic exposure to phenylephrine also leads to agonism of alpha-1 adrenergic receptors, raising systolic and diastolic pressure as well as peripheral vascular resistance. Increased blood pressure stimulates the vagus nerve, causing reflex bradycardia.
At the recent SEC meeting for pulmonary held on December 7, 2022, the expert panel reviewed the PK study protocol presented by the drug major Glenmark Pharmaceutical.
After detailed deliberation, the committee granted permission to conduct the PK study. Furthermore, the expert panel directed that the results of the study be presented before the SEC for further consideration.
