Regulatory Decision Summary for Sanoclear

Decision issued

No decision was issued by Health Canada. The company cancelled its application before a final decision was issued.

Date of cancellation

2021-09-01

What was the purpose of this submission?

Sanoclear (nitric oxide nasal spray) was submitted under the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. The purpose of this application was to obtain market authorization for Sanoclear for the indication “reduction of viral load in patients exposed to SARS-CoV-2.”

What did the company submit to support its submission?

The company submitted quality, non-clinical, and clinical data in addition to labelling and packaging components.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

At the time of the cancellation, there were no data available from Phase 3 clinical trials evaluating the safety and efficacy of nitric oxide nasal spray in the prevention or treatment of COVID-19. As the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 expires as of September 16, 2021, and in the absence of additional clinical data for evaluation by Health Canada by this time, the application was cancelled by the company. The cancellation is without prejudice to refiling under the New Drug Submission pathway, dependent upon the availability of Phase 3 data, and leveraging the modified requirements that facilitate the regulatory process for new COVID-19 drugs.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials.

Additional information

*Proposed Brand Name:
Sanoclear