FDA approves new nasal spray for allergic rhinitis

The US Food and drug administration has approved new treatment option for seasonal allergic rhinitis that combines olopatadine hydrochloride and mometasone furoate in the form of a nasal spray.

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.1,2,3

"Allergic rhinitis and allergic conjunctivitis are among the most common chronic diseases in the US today, affecting 60 million Americans each year,4 yet approximately one in seven US adults have reported their nasal allergy symptoms are either poorly controlled or not controlled at all,5 and ocular symptoms are reported to be as severe as nasal symptoms,"6 said Leonard Bielory, M.D. Professor of Medicine, Allergy, Immunology and Ophthalmology at Hackensack Meridian School of Medicine.

"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 complications7,8,9,10 which can have a significant impact on patients' quality of life.11,12,13 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.14,15,16,17,18

"The launch of RYALTRIS™ is a significant step forward for Hikma in expanding our US nasal spray leadership into branded medicines and advancing our objective of growing our specialty business in the US," 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 US patients suffering from seasonal allergic rhinitis."

"We are delighted to partner with Hikma for the launch of our novel drug RYALTRISTM in the United States, making it our first global branded specialty product to be marketed in the country.

RYALTRISTM 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," said Brendan O'Grady, Chief Executive Officer - Global Formulations Business, Glenmark Pharmaceuticals Ltd.

References:

1. Patel P, et. al. Ann Allergy Asthma Immunol. 2019;122(2):160-166

2. Gross GN, et. al. Ann Allergy Asthma Immunol. 2019;122(6):630-638

3. Hampel FC, et. al. Allergy Asthma Proc. 2019;40(4):261-272

4. Meltzer EO. Immunol Allergy Clin North Am. 2016;36(2):235-248

5. Meltzer E, et al. Allergy Asthma Proc. 2012;33 (suppl 1):113-141.

6. Bielory L, et al. Allergy Asthma Proc. 2014 ;35(3):211-8..