The Food and Drug Administration (FDA) has granted Fast Track designation to ATRS-1902 for the treatment of acute adrenal insufficiency in adults and adolescents.
ATRS-1902 is an investigational rescue treatment that uses a proprietary autoinjector to deliver a liquid stable formulation of hydrocortisone. The designation was based on phase 1 study results, which showed ATRS-1902 (100mg) delivered a comparable pharmacokinetic profile to Solu-Cortef ® (hydrocortisone for IV or IM injection; 100mg) in 32 healthy adults. ATRS-1902 was also found to be safe and well tolerated.
“We are very pleased that ATRS-1902 has received Fast Track designation from the FDA, a distinction that underscores the urgent need for an improved therapy for these patients who suffer from a potentially life-threatening situation,” said Dr Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma. “We look forward to working closely with the agency as we advance our development of ATRS-1902 with an upcoming pivotal clinical study and an additional human factor study that we anticipate will support our 505(b)(2) NDA submission by the end of the year.”
The FDA’s Fast Track designation helps to accelerate the development and review of products for serious and life-threatening diseases where no treatment exists or where the investigational therapy is likely to provide an advantage over currently available treatments.
- Antares Pharma receives FDA Fast Track designation for ATRS-1902 for adrenal crisis rescue. News release. Accessed January 18, 2022. https://www.globenewswire.com/news-release/2022/01/18/2368333/35385/en/Antares-Pharma-Receives-FDA-Fast-Track-Designation-for-ATRS-1902-for-Adrenal-Crisis-Rescue.html.
- Antares Pharma announces positive results from phase I study for ATRS-1902 for adrenal crisis rescue. News release. Accessed January 18, 2022. https://www.globenewswire.com/en/news-release/2022/01/11/2364736/35385/en/Antares-Pharma-Announces-Positive-Results-From-Phase-I-Study-For-ATRS-1902-For-Adrenal-Crisis-Rescue.html.
Source: Medical Bag https://www.medicalbag.com/home/news/hydrocortisone-rescue-pen-fast-tracked-for-adrenal-insufficiency/