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Methotrexate Gets Orphan Drug Status for Treatment of Ectopic Pregnancy

Subcutaneous Agent Could Prevent Laparoscopic Surgery, Emergency Surgery

Antares Pharma, Inc. has received an orphan drug designation for subcutaneous methotrexate for the treatment of ectopic pregnancy. The company plans to set up a program using a proprietary auto-injector device with doses of methotrexate, which could eliminate the need for laparoscopic surgery or emergency surgical intervention.

If left untreated, an ectopic pregnancy may continue to grow, rupturing the fallopian tube (where the nonviable pregnancy tissue tends to be located) and causing massive hemorrhaging followed by the death of the patient. Most cases of unruptured ectopic pregnancy can be successfully treated with laparoscopy or by using intramuscular methotrexate in an “off-label” manner.

Approximately 128,000 ectopic pregnancies occur each year in the U.S. In spite of improvements in diagnosis and management, the condition remains a major cause of pregnancy-related morbidity and mortality. Hemorrhage from ectopic pregnancy is the primary cause of pregnancy-related maternal death in the first trimester, accounting for 4% to 10% of all pregnancy-related deaths in the U.S.

Subcutaneous methotrexate could effectively treat ectopic pregnancies, without the need for laparoscopic surgery or emergency surgical intervention, removing the risk of rupture, hemorrhage, and death. This, in turn, may reduce both patient morbidity rates and health care costs. Furthermore, treatment with methotrexate has the potential to preserve future fertility, potentially preventing the need for surgical intervention or future infertility intervention.

The subcutaneous approach utilizing our proprietary auto injector technology may reduce patient discomfort when compared to traditional intramuscular injections.

Source: Antares Pharma, March 28, 2019

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