Ravenbhel Gets SEC Nod to Market Bilastine, Montelukast FDC, Phase IV Trial Mandated

New Delhi: Waiving the requirement for bioequivalence (BE) and Phase III clinical trials, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Ravenbhel Healthcare for manufacturing and marketing the fixed-dose combination (FDC) of Bilastine 10 mg plus Montelukast Sodium IP equivalent to Montelukast 4 mg per 5 mL oral solution, with a condition to conduct a Phase IV clinical trial.

This came after the firm presented justification for BE and the Phase III CT waiver before the committee along with a special invitee (Pediatrician).

The committee noted that the said FDC is already approved in suspension and orodispersible tablets, i.e.,

 Bilastine 10 mg + Montelukast Sodium IP eq. to Montelukast 4 mg per 5 ml suspension on 11.03.2022.

 Bilastine 10 mg + Montelukast Sodium IP Eq. to Montelukast 4 mg Orodispersible tablet on 09.05.2022.

Bilastine and montelukast sodium is a combination prescription medicine used to treat allergic conditions such as allergic rhinitis (hay fever) and asthma. Bilastine is an anti-allergic medication. It treats allergy symptoms such as itching, swelling, and rashes by blocking the effects of a chemical messenger (histamine) in the body. Montelukast works by blocking the action of leukotriene, a chemical messenger. This reduces inflammation in the airways to prevent asthma and relieve symptoms of allergies.

Bilastine is a peripheral histamine H1-antagonist used to treat seasonal allergic rhinitis and chronic spontaneous urticaria. During an allergic response, mast cells undergo degranulation which releases histamine and other substances. By binding to and preventing activation of the H1 receptor, bilastine reduces the development of allergic symptoms due to the release of histamine from mast cells.

Montelukast is a leukotriene receptor antagonist used as part of an asthma therapy regimen to prevent exercise-induced bronchoconstriction and to treat seasonal allergic rhinitis.

Montelukast binds with high affinity and selectivity to the CysLT type 1 receptor, which consequently assists in inhibiting any physiological actions of CysLTs like LTC4, LTD4, and LTE4 at the receptor that may facilitate asthma or allergic rhinitis.

At the recent SEC meeting for Pulmonary drugs, the expert panel reviewed the justification for BE and the Phase III CT waiver presented by Ravenbhel Healthcare.

After detailed deliberation, the committee considered the request for a BE and Phase III CT waiver and recommended granting permission for manufacturing and marketing with the condition to conduct the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC for review by the committee.