Recent data gleaned from a successful Phase III study of Selexipag sent stock prices up fifteen percent for the pharmaceutical company Actelion. As an efficacious next generation treatment for pulmonary arterial hypertension, also known as PAH, Selexipag has been forecasted by pharmaceutical analysts to become the next blockbuster drug. The advent of Selexipag as an oral therapy treatment for patients with PAH makes this drug desirable for ease of use and the increased likelihood of patient medication adherence. Phase III results shined bright as well, revealing a 39 percent reduced risk in mortality over a placebo in patients dosed with Selexipag.
The Phase III study involved 1,156 patients with PAH, which is defined hypertension in the arteries of the lung, causing life-threatening pressure and stress on the heart. Patients suffering from this serious disease experience shortness of breath during everyday activity, exhaustion, pain in the chest and a faster than normal heartbeat. These debilitating symptoms often lead to patients to severely limit their overall physical activity, which significantly affects their quality of life. The good news is that top-line results from the Phase III study, coined GRIPHON, showed that primary efficacy endpoints were met. Patients who were treated for approximately 4.3 years on average with Selexipag demonstrated tolerable and successful results.
In June 2014, Actelion announced the encouraging top-line results of the pivotal Phase III GRIPHON study involving patients with PAH who were treated with Selexipag. Compared to a placebo the initial analysis showed that the event-driven outcome study met its primary efficacy endpoint with statistical significance. While dosing was determined on an individual basis, initial dosages started at 200 micrograms twice a day for all patients in the study. Patients were then evaluated and those who needed and were able to tolerate a dose increase were administered an additional 200 micrograms twice daily, with a maximum of 1600 micrograms two times a day. As typical with prostacyclin therapies, common side effects included diarrhea, nausea, headache and flushing.
As the first selective oral prostacyclin IP receptor agonist Selexipag looks like a boon to the pharmaceutical industry as well as a viable treatment for patients suffering from pulmonary arterial hypertension.
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