FDA Rejects Emergency Treatment for Severe Allergic Reaction

Agency requests expanded studies

Adamis Pharmaceuticals has received a complete response letter (CRL) from the FDA regarding its new drug application (NDA) for an epinephrine injection USP 1:1,000 0.3 mg prefilled single-dose syringe (PFS) product. It’s the drug’s second rejection. The company is seeking approval for the emergency treatment of acute anaphylaxis––a severe allergic reaction.

A CRL is issued by the FDA’s Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.

Because of improvements that were made to the PFS in response to the FDA’s original CRL dated March 27, 2015, the agency indicated that, to support approval of the product, Adamis must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA. Adamis believes that it can complete the additional testing within a relatively short period, and plans to submit the data to the FDA in the second half of 2016. The company has successfully addressed the “volume delivery” issue that was associated with the initial CRL.

The FDA has indicated that the NDA will remain open until these issues are resolved.

Source: Adamis Pharmaceuticals, June 6, 2016.