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news.MEDA, a specialty pharma company engaged in marketing and product development in late clinical phase, has filed a new drug application (NDA) with the US Food and Drug Administration (FDA) for a novel formulation of azelastine hydrochloride and fluticasone propionate, tentatively named as Dymista.
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Dymista (also known as MP29-02 in clinical trials), is a nasal spray formulation for patients 12 years and older with seasonal allergic rhinitis.
Efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long term safety study with more than 600 patients.
In Dymista Phase III clinical trial evaluating in patients with seasonal allergic rhinitis (SAR), the nasal spray improved the Total Nasal Symptom Score (TNSS) compared to placebo and either fluticasone or azelastine alone during a 14-day treatment period.
Dymista demonstrated a 40% improvement in TNSS relative to fluticasone.
Dymista was effective for treating all individual symptoms of the TNSS, including nasal congestion vs. fluticasone.