SAN DIEGO – ARS Pharmaceuticals, a pharmaceutical company developing a needle-free epinephrine nasal spray to treat allergic reactions, has received approval from the U.S. Food and Drug Administration (FDA).
The publicly traded company’s nasal spray, called neffy, is the first needle-free emergency treatment for potentially fatal allergic reactions, according to the firm’s executives. In particular, the product has potential to serve as an alternative to EpiPen and other autoinjectors.
President & CEO
ARS Pharmaceuticals
“The FDA approval of neffy is an important initial milestone in fulfilling our commitment to the allergy community,” Richard Lowenthal, chief executive officer and president of ARS Pharmaceuticals told the San Diego Business Journal.
“The advancement of medical innovation is never a straight line. But our team has been steadfast and resilient in navigating obstacles in our journey and never wavered in our focus on fulfilling the needs of the allergy community,” said Lowenthal.
Since the announcement of neffy’s FDA approval on Aug. 9, ARS Pharmaceutical (Nasdaq: SPRY) have shot up roughly 35%, from just below $10 a share to currently trading at around $13.50.
Treating Allergic Reactions
Since its founding in 2015, ARS Pharmaceuticals has specialized in developing products that can help reduce severe allergic reactions at the first sign of symptoms.
The spray is a life-saving drug used by people at risk of anaphylaxis and other allergic reactions.
With the recent FDA approval of the nasal spray, the Carmel Valley-based company finds itself well-positioned to commercial its product in the United States, Europe, as well as Japan, China, Australia and New Zealand.
“Now that we have achieved FDA approval, we are focused on the market launch of neffy and the uptake of its use as the top epinephrine treatment through a robust commercialization program,” said Lowenthal.
“We plan to submit a supplemental New Drug Application to the FDA for the 1 mg neffy dose for children weighing less than 66 pounds. In addition, we plan to develop a lower dose of neffy and a modified device for babies/toddlers weighing less than 33 pounds,” said Lowenthal.
Commercialization Strategy
ARS Pharma will offer neffy at a price of $199 for two doses via digital pharmacy sites like BlinkRx and GoodRx for eligible patients whose insurance plans do not cover neffy.
ARS Pharma’s strategy is focused on developing and advancing to market a suite of neffy programs, said Lowenthal. It will start with additional expansion in its pediatric labeling.
The company is currently conducting clinical studies to support the expansion of labeling for neffy to outpatient epinephrine use in other Type I allergy conditions such as chronic spontaneous urticaria (CSU), also known as “hives.”
“Some people, particularly children, may delay or avoid treatment due to fear of injections,” said Kelly Stone, an associate director at the FDA’s Center for Drug Evaluation and Research, adding that the availability of the nasal spray may reduce barriers to rapid treatment.
Last year, the U.S. health regulator declined to approve the spray and requested additional testing. Now with recent approval, Neffy has the potential to be a “game changer for the community.”
“The broader population of approximately 3.3 million patients who have received a prescription, but either refused or discontinued treatment,” said Lowenthal.
Lowenthal also noted that more than 13 million patients who are diagnosed and under the care of physicians but have not been prescribed an epinephrine intra-muscular injectable over the last three-years.
Investors are optimistic that Neffy may be able to target other conditions in addition to Type I allergic reactions. Down the line, the company also plans to treat patients that have acute exacerbations or flares and need periodic intervention.
Looking Ahead
In 2021, the pharmaceutical startup raised a $55 million in Series D funding in preparation for the launch of its lead product.
Twelve months later, ARS Pharma went public after merging with Silverback Therapeutics, which help them raise over $280 million in cash and securities.
It also spent some of that capital building out its commercial team, recruiting a chief commercial officer, as well as key marketing positions.
The company currently has more than 40 full-time employees, and 14 based in San Diego.
For decades, San Diego has had a stellar reputation as a hub for biotech innovation. For example, Salk Institute, Scripps Research, and other research organizations have been critical in training the next generation of scientists and medical experts.
“San Diego is now-well positioned as one of the major innovation hubs in the United States, making it an ideal location for ARS Pharmaceuticals to pursue our own innovation agenda,” said Lowenthal. “This success has brought an influx of bright minded scientists and other professionals to the San Diego area to make their mark in life sciences, biotechnology, medical devices, and numerous fields that impact the future of human health.”
ARS Pharmaceuticals
FOUNDED: 2015
CEO: Richard Lowenthal
HEADQUARTERS: Carmel Valley, San DIego
EMPLOYEES: 40+
STOCK: SPRY (Nasdaq)
REVENUE: pre-revenue
BUSINESS: Developing products that can help reduce severe allergic reactions.
WEBSITE: www.ars-pharma.com
NOTABLE: Went public in 2022 after merging with Silverback Therapeutics, which help they raised over $280 million in cash and securities.
