Justify dose of Bilastine: CDSCO Panel tells Glenmark on FDC of Bilastine, Dextromethorphan ,Phenylephrine Syrup
New Delhi: Rejecting the pharmaceuticals major Glenmark proposal for bioequivalence (BE) study waiver of fixed dose combination drug Bilastine 3.3mg plus Dextromethorphan Hydrobromide 10mg plus Phenylephrine Hydrochloride 5mg Syrup, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the firm to justify the dose of Bilastine in the proposed FDC for further review by the committee.
This came after the firm presented the Phase III clinical trial protocol and requested for BE study waiver before 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 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 for Pulmonary held on 28.04.2022, the expert panel reviewed the Phase III clinical trial protocol and request for the BE study waiver in detail.
During the presentation, the committee noted that Bilastine 6.6 mg t.i.d is not approved internationally.
In addition the expert panel suggested that clinical trial protocol for appropriate phase of the study should be revised accordingly and sedation should also be included in the clinical trial protocol as one of the endpoint.
After detailed deliberation, the committee recommended that the firm should initially justify the dose of Bilastine in the proposed FDC for further review by the committee.
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