FDA Accepts Medac Pharma's NDA For MPI-2505
By Cyndi Root
Medac Pharma, Inc. announced in a press release that the Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for MPI-2505 (methotrexate). Methotrexate (MTX) treats psoriasis, rheumatoid arthritis (RA), and poly-articular-course juvenile RA. The drug is delivered via an injection device, also called an autopen. The parent company, medac GmbH, is also applying for a patent for the subcutaneous injection method dispensing MTX at more than 30 mg/ml.
Terri Shoemaker, President and CEO of Medac Pharma, Inc. said, “While methotrexate has proven itself as a highly effective medicine for treating several forms of arthritis, there remains a substantial need to make treatment for this patient demographic more manageable.” The autopen improves bioavailability of the drug and sidesteps issues with oral or liquid MTX doses. The CEO of Medac believes that expanding drug delivery options improves efficacy of the medication and provides new resources for immunology therapies.
MTX primarily targets RA, an autoimmune disease requiring lifelong management with drugs. Patients experience swollen and painful joints, fever, and lack of energy. MTX is a drug of choice for this disease and other rheumatic conditions. MTX has been used for other inflammatory arthritis diseases, cancer, lupus, and vasculitis. The drug works by blocking enzymes in the immune system.
Standard doses are 2.5 mg tablets. Adults usually take three or four pills once a week with increases to 25 mg per week possible as the disease progresses. Patients can also take the medication in liquid form. At higher doses, the injection method is indicated in order to reduce side effects. MTX can cause vomiting, mouth sores, diarrhea, and rashes. Patients undergo frequent tests to detect liver damage, with cirrhosis a rare side effect. Pregnant patients should not take the drug, as it can cause severe birth defects.
About Medac Pharma, Inc.
Medac Pharma, Inc. is a subsidiary of medac GmbH. The two companies are globally positioned pharmaceutical companies marketing products in over 70 countries. Medac concentrates on inventing products that maximize drug concentrations and efficiency, reduce side effects, and improve safety profiles. The company expects to market the MTX autopen after FDA approval, later in 2014.
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