Antares Pharma, Inc. today announced that the New Drug Application (NDA) for OTREXUP, a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet technology, has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 14, 2013, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.
“The FDA’s acceptance of the OTREXUP NDA is an important start to the review process and a significant milestone for our shareholders,” said Paul K. Wotton Ph.D., President and Chief Executive Officer. “We look forward to working closely with the FDA during their review of the application.”
About Medi-Jet and Methotrexate
Medi-Jet is a proprietary parenteral drug delivery system protected by several issued and pending patents. Medi-Jet is designed to enable patients to quickly and easily self-administer a drug subcutaneously or intramuscularly, reliably and comfortably while also enhancing safety with an integrated, shielded needle that protects against accidental needle stick and drug exposure. Medi-Jet is a trademark of Antares Pharma.
Methotrexate is a commonly prescribed disease-modifying anti-rheumatic drug (DMARD), for the treatment of RA, used in a majority of patients either on its own or in combination with biological therapies.
About Antares Pharma
Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. The Company is developing OTREXUP, a combination product for the delivery of methotrexate using Medi-Jet technology for the treatment of rheumatoid arthritis, poly-articular-course juvenile rheumatoid arthritis and psoriasis, as well as VIBEX QS T for testosterone replacement therapy. The Company's technology platforms include VIBEX disposable Medi-Jet, disposable multi-use pen injectors and Vision reusable needle-free injectors marketed as Tjet® and Zomajet® by Teva Pharmaceutical Industries, Ltd (Teva) and Ferring Pharmaceuticals (Ferring), respectively. Antares Pharma has a multi-product deal with Teva that includes Tev-Tropin® human growth hormone (hGH), VIBEX epinephrine and several other products. Antares Pharma’s partnership with Ferring includes Zomacton® hGH. In the U.S. Antares has received FDA approval for Gelnique 3%, a treatment for overactive bladder that is marketed by Actavis. Elestrin® (estradiol gel) is FDA approved for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and is marketed in the U.S. by Meda Pharma. Antares Pharma has two facilities in the U.S. The Parenteral Products Group located in Minneapolis, Minnesota directs the manufacturing and marketing of the Company’s reusable needle-free injection devices and related disposables, and develops its disposable pressure-assisted Medi-Jet and pen injector systems. The Company’s corporate office and Product Development Group is located in Ewing, New Jersey.