Antares Pharma Says FDA Okays Three New Dosage Strengths Of OTREXUP Injection

(RTTNews) - Antares Pharma Inc. (ATRS) announced the approval by the U.S. Food and Drug Administration of three new dosage strengths of OTREXUP (methotrexate) injection. The new dosage strengths of 12.5 mg/0.4 ml, 17.5 mg/0.4 ml and 22.5 mg/0.4 ml will complement the already approved and marketed strengths of 7.5 mg/0.4 ml, 10 mg/0.4 ml, 15 mg/0.4 ml, 20 mg/0.4 ml, and 25 mg/0.4 ml. New, interim dose-strength options will enable physicians to select more specific, optimal doses to help achieve patient treatment goals.

"OTREXUP™ has always been available in the most commonly prescribed strengths of methotrexate, but our new interim dose options may provide physicians even more opportunity to give their patients precisely what is needed to achieve disease control," said Robert Apple, President and Chief Executive Officer of Antares Pharma. "Each and every patient treatment regimen is different, so providing a step approach to therapy may extend and optimize the use of OTREXUP™ for patients. New interim strengths are also covered by OTREXUP™ TotalCare so all eight dosing options are eligible for up to $125 of patient co-pay assistance."

OTREXUP™ was the first FDA-approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. OTREXUP™ is indicated for adults with severe active rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of first line therapy including full dose non-steroidal anti-inflammatory agents. In addition, OTREXUP™ is also approved for use in children with active polyarticular juvenile idiopathic arthritis as well as for use in adults for symptomatic control of severe recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy.