ATRS: Fast Track for Adrenal Crisis Rescue ATRS-1902
Jan 18, 2022 13:43:34 GMT
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Post by icemandios on Jan 18, 2022 13:43:34 GMT
Antares Pharma Receives FDA Fast Track Designation for ATRS-1902 for Adrenal Crisis Rescue
EWING, N.J., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for ATRS-1902 for adrenal crisis rescue. The development program for ATRS-1902 supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using our Vai™ novel proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone.
The FDA’s Fast Track designation process is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may provide advantages over what is currently available. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.
“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. 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,” commented Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma.
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, “This designation by the FDA represents an important milestone for the clinical development of ATRS-1902. We appreciate the opportunity to work more collaboratively with the FDA on our hydrocortisone rescue pen. ATRS-1902 is one of many rescue pen products that we are currently developing for ourselves or for our partners that we believe can benefit patients with serious medical conditions and support our future growth.”
Antares also recently announced positive results of the Phase I cross-over study for ATRS-1902 that met its primary objective showing ATRS-1902 (100 mg) delivered a comparable pharmacokinetic profile to Solu-Cortef ® (100 mg), the reference-listed drug, in 32 healthy adults.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO ® (testosterone undecanoate) in the U.S. pending final FDA approval.
EWING, N.J., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Antares Pharma, Inc. (NASDAQ: ATRS) (the “Company”), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation for ATRS-1902 for adrenal crisis rescue. The development program for ATRS-1902 supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using our Vai™ novel proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone.
The FDA’s Fast Track designation process is designed to accelerate the development and review of treatments for serious and life-threatening diseases where no treatment exists or where the treatment in discovery may provide advantages over what is currently available. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process and a rolling and/or priority review of its marketing application if relevant criteria are met.
“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. 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,” commented Dr. Peter Richardson, MRCP (UK), EVP, Research and Development and Chief Medical Officer of Antares Pharma.
Robert F. Apple, President and Chief Executive Officer of Antares Pharma, added, “This designation by the FDA represents an important milestone for the clinical development of ATRS-1902. We appreciate the opportunity to work more collaboratively with the FDA on our hydrocortisone rescue pen. ATRS-1902 is one of many rescue pen products that we are currently developing for ourselves or for our partners that we believe can benefit patients with serious medical conditions and support our future growth.”
Antares also recently announced positive results of the Phase I cross-over study for ATRS-1902 that met its primary objective showing ATRS-1902 (100 mg) delivered a comparable pharmacokinetic profile to Solu-Cortef ® (100 mg), the reference-listed drug, in 32 healthy adults.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug delivery auto injector technology. The Company has a portfolio of proprietary and partnered commercial products with several product candidates in various stages of development, as well as significant strategic alliances with industry leading pharmaceutical companies including Teva Pharmaceutical Industries, Ltd. (Teva), AMAG Pharmaceuticals (AMAG), Pfizer Inc. (Pfizer) and Idorsia Pharmaceuticals Ltd. (Idorsia). Antares Pharma’s FDA-approved products include XYOSTED ® (testosterone enanthate) injection and Sumatriptan Injection USP, which is distributed by Teva. The Company also markets NOCDURNA ® (desmopressin acetate) in the U.S. and expects to commercially launch TLANDO ® (testosterone undecanoate) in the U.S. pending final FDA approval.