Ryaltris is a new nasal spray (formerly GSP301) that is being investigated by Glenmark Pharmaceuticals for the treatment of seasonal allergic rhinitis in patients 12 years and older. Ryaltris consists of 2 drugs, the first one is olopatadine hydrochloride, a nasal antihistamine, which is the medication used in Patanase nasal spray. The second medication is a steroid, mometasone furoate monohydrate, which is the active ingredient for Nasonex nasal spray.
Using both of these medications together would make it easier for patients than using 2 separate nasal sprays. Nasal steroids and nasal antihistamines have both been shown to be effective in the treatment of allergic rhinitis. Approximately 50% of patients with allergic rhinitis need more than 1 medication and Ryaltris would meet the need of many of those patients. The gold standard to treat allergic rhintis, is a nasal steroid spray.
If the type of ingredients of Ryaltris sounds familiar, it is. Dymista nasal spray is also a combination of a nasal steroid (fluticasone propionate 50 mcg) and an antihistamine (azelestine hydrochloride 137 mcg). Many patients have enjoyed the convenience of using 1 nasal spray over 2, but many insurance companies balked at paying a higher price for Dymista. Insurances have required prior authorizations or they were excluded from drug formularies, making it difficult for patients to obtain. Ryaltris may have the same difficulties moving forward. In terms of efficacy of Ryaltris vs Dymista, they both have the same classes of medications, no studies have shown one superior to the other, but Dymista’s ingredient, azelestine has been known to have a bitter taste to it.
Allergic rhinitis is an inflammatory disease that affects 16 million adults and 5.5 million children in the United States. It can affect quality of life, decrease work and school productivity, disturb sleep, cause fatigue, irritability and depression.
An intranasal antihistamine can give fast-acting relief and an intranasal corticosteroid can be effective long term. Using a single device combination treatment can improve treatment adherence. Olopatadine when applied intranasally reduces itchy/runny nose and sneezing. Mometasone reduces nasal itching and congestion, sneezing and runny nose by inhibiting the release of inflammatory mediators and it has a well documented safety profile with minimal systemic effects.
A recent study looked at Ryaltris titled “Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study” evaluated the efficacy of this new spray. The conclusion found that in an environmental exposure chamber model, twice-daily and once daily Ryaltris treatments were well tolerated and provided statistically significant and clinically meaningful allergic rhinitis symptom improvement vs placebo.
Stay tuned for the release of Ryaltris, it is not known at the present time what the cost will be and whether or not medical insurance will cover it. Here is the press release from Glenmark Pharmaceuticals regarding Ryaltris.
Update July 24, 2019
A study published in the Annals of Allergy Asthma and Immunology titled “Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of allergic rhinitis” performed more studies into GSP301 (Ryaltris). They looked at patients with seasonal allergic rhinitis over 12 years of age. A total of 1176 patients were enrolled. The results showed that Ryaltris improved over ocular symptoms, individual nasal and ocular symptoms and quality of life vs. placebo. Onset of action was 15 minutes and maintained at all timepoints. Ryaltris showed better improvement than monotherapy with each of the ingredients alone. The most frequent reported side effect was bad taste and nasal discomfort, but otherwise it is well tolerated.
Update March 24, 2020
In a study published in the Annals of Allergy, Asthma, and Immunology titled “Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis”, it looked into GSP301 to evaluate efficacy and safety in patients with seasonal allergic rhinits. The study concluded that twice-daily Ryaltris treatment was efficacious and well tolerated, providing statistically significant and clinically meaningful improvements vs. placebo and both monotherapies.