FDA Approves Self-Administrating Injectable Methotrexate


Methotrexate 59-05-2 FDA ApprovalThe recent approval by the FDA for the Methotrexate injection was encouraging news for patients with rheumatoid arthritis. The FDA gave a nod to approve Methotrexate as the brand name OTREXUP, which is marketed by Antares Pharma on October 16, 2013. This subcutaneous injectable treatment is quite novel, as it is the very first and thus far only self-administering injectable treatment for patients with rheumatoid arthritis. Other indications for this easily administered injectable medication are for the treatment of psoriasis and poly-articular-course juvenile rheumatoid arthritis. The uniquely tolerable method for administering Methotrexate was shown in studies to appeal to patients. Delivering this injection subcutaneously is seamless, with the patient pressing the injectable device on their skin for about three seconds to administer their dose. Coined the Medi-Jet, this parenteral drug delivery system is distinctive as no needle is ever seen by the patient. There is also an inventive needle shield which prevents the patient from getting accidental additional needle sticks. Study participants have proclaimed that using the device is virtually pain free.

Methotrexate as the cutaneous injection is designed as a safe and usable auto-injector for patients who have severe rheumatoid arthritis (RA) and children with poly-articular-course juvenile rheumatoid arthritis (PJIA), after other standard treatments and medications have not been successful. Methotrexate is also now approved to treat the symptoms of psoriasis in adults which is deemed as severe, disabling and resistant to previously explored treatments. Severe adverse effects from Methotrexate are rare, and most patients displayed minor side effects. Most common side effects reported included nausea, dyspepsia, rashes, mouth sores and stomach upset. Methotrexate is prescribed for roughly 70 percent of patients suffering from RA, and is typically dispensed alongside biological therapies or as a standalone treatment. The titration of Methotrexate is common, with many adult patients starting at a low dose of 7.5 milligrams once a week, with the maximum dose being 25 milligrams once weekly.

Methotrexate Injectable FDA ApprovedThe FDA approved Otrexup based on the positive data that showed it’s subcutaneous delivery of the medication was superior when compared to oral delivery. However, injectable methotrexate is already used by rheumatologists, delivering superior levels of the drug into the blood, and is currently available with a cheaper price tag. In addition, injectable methotrexate is rarely prescribed by doctors, as this method of treatment requires a weekly visit to the doctor. Ultimately, with the RA and psoriasis markets totaling over twenty billion dollars in estimated profit {RA-17 billion and psoriasis 5 billion} the injectable Methotrexate stands to become a profitable treatment for this packed patient population.

LGM Pharma provides the Methotrexate CAS# 59-05-2 API for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

  • Share: