Hikma advances its epinephrine nasal spray with multi-market regulatory filings

Hikma’s epinephrine nasal spray moves into regulatory review across major markets but remains unapproved and its clinical benefit unproven.

Rhea-AI Summary

Hikma Pharmaceuticals (HKMPF) has had regulatory submissions for its investigational epinephrine nasal spray for emergency treatment of anaphylaxis accepted for review in the United States, Europe and the UK.

In the US, the FDA has accepted a 505(b)(2) New Drug Application including non-clinical and clinical data. In Europe and the UK, a hybrid marketing authorisation dossier has been validated and accepted via the Decentralised Procedure and National Procedure respectively, targeting authorisation in multiple markets. Hikma has also filed in Canada and plans further global filings. The product remains investigational, is not approved by the FDA, and its safety and efficacy have not been established.

Positive

• FDA NDA accepted for epinephrine nasal spray under 505(b)(2) pathway in US
• Hybrid dossier validated for review across multiple European and UK markets
• Additional filing in Canada with plans for further market submissions

Negative

• Product remains investigational with no FDA approval to date
• Safety and efficacy not established by the FDA
• Company states there is no assurance the product or any indication will receive regulatory approval

AI-generated analysis. How Rhea-AI works. Not financial advice.

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LONDON, Sept. 10, 2026 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma, Group) announces that regulatory submissions for its epinephrine nasal spray, being developed for the emergency treatment of allergic reactions (anaphylaxis), have been accepted for review by regulators in the United States, Europe, and the UK. Hikma has also filed a submission for its epinephrine nasal spray in Canada, with plans to expand filings beyond these markets in due course. 

Hikma's epinephrine nasal spray is an investigational, non-injectable product designed for the emergency treatment of allergic reactions (anaphylaxis).

In the United States, the US Food and Drug Administration (FDA) has accepted for review the New Drug Application for Hikma's epinephrine nasal spray. This 505 (b) (2) submission is comprised of the required non-clinical and clinical data package for the approval of the nasal spray for the emergency treatment of anaphylaxis in patients. In Europe and the UK, Hikma's hybrid marketing authorisation dossier for the nasal spray has been validated and accepted for review through the Decentralised Procedure (DCP) and National Procedure respectively, with a view to authorisation across multiple European and UK markets.

"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," said Hafrun Fridriksdottir, President Hikma US and Chief R&D Officer. "This reflects our continued focus on developing differentiated and innovative medicines, leveraging our manufacturing expertise and broadening affordable access for patients around the world."

Hikma's epinephrine nasal spray is an investigational product and has not been approved by the FDA. The safety and efficacy of Hikma's product have not been established by the FDA.

Hikma has submitted its epinephrine nasal spray for regulatory review by the FDA. Submission of an application does not mean that the FDA has approved the application or determined that Hikma's epinephrine nasal spray is safe or effective.  There can be no assurance that Hikma's epinephrine nasal spray product or any particular indication for that product will receive regulatory approval.

About Hikma Pharmaceuticals PLC
Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,400 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

Enquiries    

Hikma Pharmaceuticals PLC  

Susan Ringdal EVP, Strategic Planning and Global Affairs	+44 (0)20 7399 2760/ +44 7776 477050
Steven Weiss US Communications	+1 732 788 8279

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SOURCE Hikma Pharmaceuticals USA Inc.

FAQ

What is Hikma’s epinephrine nasal spray intended to treat?

Hikma’s epinephrine nasal spray is being developed as a non-injectable product for the emergency treatment of allergic reactions (anaphylaxis).

Which regulatory procedures are being used in Europe and the UK?

In Europe, the epinephrine nasal spray is being reviewed through the Decentralised Procedure as part of a hybrid marketing authorisation dossier, while in the UK it is being reviewed under a National Procedure.

Has the FDA determined that Hikma’s epinephrine nasal spray is safe or effective?

No. The company states that acceptance of the submission does not mean the FDA has approved the application or determined that the product is safe or effective, and there can be no assurance it will receive regulatory approval.

Does Hikma plan to seek approval in markets beyond the US, Europe, UK and Canada?

Yes. Hikma has filed in Canada and, in the company’s words, plans to expand filings beyond these markets in due course.