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      Adrenaline Nasal Spray for Allergic Reactions Approved by FDA Fast Track

      Author : admin Time : 2019-11-28Click :

      An allergic reaction is an acute, life-threatening condition that requires urgent treatment. On August 30, INSYS Therapeutics, a biological company that develops, manufactures, and commercializes medicinal cannabinoids and spray administration technologies, announced that the US FDA has granted the company research on Epinephrine Nasal Spray for the treatment of allergic reactions Fast track status.

      According to the Mayo Clinic, more than 200,000 allergic reactions occur each year in the United States. The World Allergy Organization estimates that up to 2% of the world's population (up to 150 million people) will experience an allergic reaction in their lifetime.

      In a previous clinical trial, an intranasal adrenaline candidate from INSYS showed the potential of a needle-free, non-invasive, and easy-to-use alternative to intramuscular injection to treat allergic reactions. The preliminary results of this pharmacokinetic study involving 60 patients with seasonal allergies show that the epinephrine nasal spray under study can achieve rapid drug absorption, and its bioavailability and intramuscular injection of EpiPen? (0.3 mg) is similar.

      Steve Sherman, senior vice president of regulatory affairs at INSYS Therapeutics, said: "The grant of Fast Track status marks an important milestone for INSYS and a major milestone in our development of this new drug device. We look forward to working with the FDA to make it possible to Auto-injector alternatives are available to those interested as soon as possible. "

      INSYS utilizes patented spray technology and cannabinoid drug development capabilities, and is developing a series of products designed to address unmet medical needs and clinical deficiencies of existing commercial products. The company focuses on opioid addiction, opioid overdose, epilepsy And other areas of medicine where serious needs are unmet.

      At the end of last year, INSYS, another cannabis glycol oral solution for Prader-Willi syndrome, was also approved by the FDA. The company's medicinal cannabis glycol candidate product is also evaluating the therapeutic potential for use in childhood absence epilepsy (clinical phase 2) and infantile spasm (clinical phase 3).

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