Hikma’s epinephrine nasal spray advances into regulatory review

Hikma ($HIK) said regulators in the United States, Europe and the UK have accepted submissions for its investigational epinephrine nasal spray for review. The company has also filed in Canada and intends to expand submissions to additional markets. The product is being developed for emergency treatment of severe allergic reactions, offering a potential non-injectable delivery option.

The US application follows the 505(b)(2) regulatory pathway and is supported by the company’s clinical and nonclinical development package. Acceptance for review means the filings can proceed through assessment; it is not a marketing approval or confirmation of the proposed product’s final labeling. Hikma did not disclose a financial contribution from the candidate in this update. Commercial availability will depend on the outcome of the relevant regulatory reviews.

Sources:

• Hikma — multi-market regulatory update