Hikma launches RYALTRIS™ seasonal allergic rhinitis nasal spray in the US
RYALTRIS™ is the only fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in one easy-to-use nasal spray
60 million Americans suffer from allergic rhinitis and allergic conjunctivitis yet approximately 8.5 million are still impacted by poor nasal symptom control
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
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
"We are delighted to partner with
The efficacy and safety of RYALTRIS™ was established in a robust clinical studies program in over 4,000 patients with SAR. Twice-daily RYALTRIS™ provided statistically significant improvement in both nasal and ocular symptoms vs. placebo,1,2,3 as well as statistically significant onset of action in nasal symptom relief vs. placebo at 10-15 minutes,1,2,3 across three randomized, double-blind phase 3 studies (P<0.05). RYALTRIS™ also provided significant and clinically meaningful sustained improvements in nasal symptoms versus placebo over 52 weeks with no evidence of tachyphylaxis in patients with perennial allergic rhinitis (PAR).1,2,3 RYALTRIS™ demonstrated a safety profile consistent with placebo, monotherapy, and comparator fixed-dose-combination treatment.1,2,3
Allergic rhinitis is one of the most common chronic diseases in
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- Ryaltris™ is an intra-nasal spray and should not be administered orally, instilled in the eyes, ears or applied to the skin.
- In clinical studies, the most common adverse events that were observed in those 12 years of age and over using Ryaltris™, were altered taste (3%), nose bleeds (1%) and nasal discomfort (1%).
- Ryaltris™ should not be used by anyone who has had an allergic reaction to olopatadine or mometasone.
- Close medical supervision is required in anyone who has a weakened immune system, including those who have had infections with opportunistic pathogens. Increased risk of occurrence or potential worsening of pre-existing infections (e.g. tuberculosis) with fungi, bacteria or viruses can occur; including fatal chickenpox, measles and herpes infections in susceptible patients.
- Ryaltris™ should be used under close medical supervision in anyone who has had nose bleeds or nasal perforation. Recurrence, worsening or persistence of these nasal problems can occur.
- Close growth monitoring of pediatric patients (12 years and over) by a medical practitioner is recommended with the use of Ryaltris™.
- Ryaltris™ effect on pregnancy and through transmission in breast milk is not known. Talk to your doctor if you are pregnant, plan to become pregnant or breastfeeding, to ensure it is safe for you to use.
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
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.
8 Settipane RA. Allergy Asthma Proc. 1999;20(4):209-213.
9 Skoner, DP. J Allergy Clin Immunol. 2000;105(6 Pt 2) :S605-S609.
10 Chirakalwasan N, et al. Asian Pac J Allergy Immunol. 2014;32(4):276-286.
11 D'Alonzo, GE Jr.
12 Marple et al. Otolaryngol Head Neck Surg. 2007;136(suppl 6):S107-S124.
13 Meltzer EO, et al. Allergy Asthma Proc. 2012;33(suppl 1):S113-S141.
14 Seidman MD, et al. Otolaryngol Head Neck Surg. 2015;152(1S):S1-S43.
15 Bhattacharyya N, et al. The Laryngoscope. 2019;129:1969–1975.
16 ICER 2018 Final Report of Biologic Therapies for Treatment of Asthma Associated with Type 2 Inflammation. *2018 Wholesale Acquisition Costs x 1 year of dosing for allergic asthma (on-label indication). Use of biologics for SAR is off-label & dosing strategies are not established.
17 Gevaert P, et al. J Allergy Clin Immunol. 2013;131:110-6.
18 Wu A, et al. J Allergy Clin Immunol Pract. 2021;9:1107-17.
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