According to Hikma Pharmaceuticals, regulators in the US, Europe, and the UK have accepted submissions for the company’s epinephrine nasal spray for the treatment of anaphylaxis, and the company has also filed a submission in Canada. The company says that it filed in the US via the 505(b)(2) pathway; in Europe via the decentralized procedure; and in the UK via the national procedure.
In 2019, Hikma acquired epinephrine and naloxone nasal sprays along with unit-dose nasal spray manufacturing assets from Insys Therapeutics. The FDA had granted Fast Track designation to the Insys epinephrine nasal spray for the treatment of anaphylaxis the previous year. Hikma announced in April 2021 that the naloxone nasal spray had been approved by the FDA and would be marketed as Kloxxado. Health Canada approved Kloxxado in 2025.
Hikma US President and Chief R&D Officer Hafrun Fridriksdottir commented, “The acceptance of our regulatory submissions for Hikma’s epinephrine nasal spray in the US, Europe, and the UK represents an important growth milestone for Hikma’s complex product line and, most importantly, will provide patients and caregivers with alternate access to life-saving treatment for anaphylaxis. This reflects our continued focus on developing differentiated and innovative medicines, leveraging our manufacturing expertise and broadening affordable access for patients around the world.”
Read the Hikma press release
