MUMBAI, May 9: Pharma Major, Glenmark Pharmaceuticals, on Thursday announced positive results from a Phase 3 study of Ryaltris, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR).
The study in patients aged 6 to under 12 years met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evening Reflective Total Nasal Symptom Score (rTNSS) compared to placebo.1 Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate
[25 mcg]), also known as GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name, a release said
”It has become increasingly important to conduct studies specifically designed for pediatric patients, so that we may gain insights into potential differences in safety, efficacy and dosing compared to studies in adult and adolescent populations,” said Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals.
”We are pleased to report that the safety and effectiveness observed in this pediatric population is consistent with our overall Phase 3 development program in SAR patients 12 years of age and older. These robust data contribute to the extensive clinical background supporting the effectiveness and tolerability of
Ryaltris”.
The primary objective of the Phase 3 study was to compare the effectiveness of Ryaltris (administered as one spray in each nostril, twice daily) versus a placebo nasal spray over 14 days in pediatric subjects (aged 6 to < 12 year) with SAR. The study randomized 446 patients and 431 patients completed the study (96.6 pc).
In the study, patients treated with Ryaltris compared to placebo showed a statistically significant improvement for the primary endpoint of average morning and evening rTNSS (p=0.001).
Rates of treatment-emergent adverse events (TEAEs) were similar between Ryaltris versus placebo (10.4 pc vs. 12.0 pc, respectively).
The most common TEAEs included distortion of taste sensation (Ryaltris 1.3 pc, placebo 0.0 pc), headache (Ryaltris 1.3%, placebo 0.5 pc) and nose bleed (Ryaltris 0.9 pc placebo 2.3pc).
Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 adult and adolescent patients (12 years of age and older). Results from those clinical trials of Ryaltris have been previously presented at key medical meetings and full results from the study of Ryaltris in pediatric patients aged 6 to under 12 years of age will be published and presented at future meetings.
If approved by the FDA, Ryaltris will be commercialized by Glenmark Therapeutics Inc. USA, a wholly-owned subsidiary of Glenmark Holding, SA, that is dedicated to launching a portfolio of branded products in the therapeutic areas of respiratory and dermatology in the US.
(AGENCIES)
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PHARMA-LUPIN-AGREEMENT
Lupin and Aptissen announce exclusive distribution
agreement of Synolis VA for Canada
MUMBAI, May 9:
Pharma Major,Lupin Limited and Aptissen S.A. (Aptissen) said that they have entered into a definitive distribution agreement under which Aptissen has granted Lupin the exclusive rights to market, distribute and sell the current Aptissen products in Canada.
This includes immediate rights to distribute Synolis VA for the treatment of Osteoarthritis. Based on Statistics Canada, Osteoarthritis affects more than 10 percent of Canadians aged 15 or older, a release said.
Synolis VA (Visco-Antalgic) is the intra-articular injection product for osteoarthritis with a unique combination of Hyaluronic Acid and high concentration of Sorbitol. Synolis VA 40/80 is already approved by Health Canada and an additional strength is currently under review.
Commenting on this development, Dr. Sofia Mumtaz, President of Lupin Pharma Canada stated,”We are pleased to partner with Aptissen for marketing and distribution of Synolis VA, a branded product in Canada. This partnership helps us expand our product portfolio in the Canadian market. We remain committed to bring superior medical products and leverage our distribution strength to allow easy access to specialty medicines in the market.”
(UNI)
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