Hikma, Glenmark Specialty launch Ryaltris

Hikma and Glenmark Specialty are introducing Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray).

Ryaltris is used for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older. This launch builds upon Hikma’s leading position as one of the largest U.S. providers of nasally administered medicines used for treating seasonal allergies and advances its objective of growing its specialty business in the U.S., the company said.

Ryaltris is the only fixed-dose combination therapy that provides relief for the symptoms of SAR, both nasal and ocular in one easy-to-use nasal spray. The onset of action for nasal symptom relief occurs within 15 minutes of a patient taking the first dose, the companies said.

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“Allergic rhinitis and allergic conjunctivitis are among the most common chronic diseases in the United States today, affecting 60 million Americans each year, yet approximately one in seven U.S. adults have reported their nasal allergy symptoms are either poorly controlled or not controlled at all, and ocular symptoms are reported to be as severe as nasal symptoms,” said Leonard Bielory, professor of medicine, allergy, immunology and ophthalmology at Hackensack Meridian School of Medicine.

Bielory added, “By combining two of the most frequently prescribed medicines used to address both the nasal and ocular symptoms of seasonal allergic rhinitis into one, easy-to-use nasal spray, Ryaltris provides an important new treatment option for patients suffering from this chronic condition affecting the nose and eyes.”

Uncontrolled seasonal allergic rhinitis is a serious condition that places a substantial burden on patients and society as whole. The symptoms of allergic rhinitis can lead to chronic complications including asthma, sinusitis, hearing impairment and other allergy-related complications, which can have a significant impact on patients’ quality of life. There is an important need for new treatment options like Ryaltris to help treat seasonal allergic rhinitis, as patients who do not experience adequate symptom relief may require therapy escalation to more costly and higher-risk treatments such as immunotherapy, biologics and surgery, the companies said.

“The launch of Ryaltris is a significant step forward for Hikma in expanding our U.S. nasal spray leadership into branded medicines and advancing our objective of growing our specialty business in the United States,” said Brian Hoffmann, president of Hikma Generics. “Importantly, it will allow us to leverage our strong, existing specialty salesforce already calling on doctors within our specialty portfolio. We look forward to bringing this important new treatment option to the millions of U.S. patients suffering from seasonal allergic rhinitis.”

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“We are delighted to partner with Hikma for the launch of our novel drug Ryaltris in the United States, making it our first global branded specialty product to be marketed in the country," said Brendan O’Grady, CEO, global formulations business, Glenmark. "Ryaltris is a result of our consistent efforts to offer high-quality medicines that benefit patients around the world. Available in major markets across the globe, this launch is a major milestone for Glenmark and demonstrates our focus in strengthening our global respiratory leadership.”