Axsome Therapeutics Inc. (NASDAQ:AXSM) has been falling consistently to new lows. The stock lost 4.70% in the last trading session here is the reason why the stock is hitting new lows. Meanwhile, the biopharma has obtained a Special Protocol Assessment (SPA) agreement with the FDA regarding the Phase 3 MOMENTUM trial of AXS-07.
The MOMENTUM study will enroll about 875 patients who have experienced inadequate responses from prior use of migraine treatments. With the full support of SPA agreement, there is optimism that the MOMENTUM trial will address and achieve the required objectives. Positive results will accelerate the approval of AXS-07 for the treatment of migraine in adults. It is likely that only one Phase 3 trial will be required for the approval.
AXS-07 may result in superior efficacy, which will address patient dissatisfaction
According to the Centers for Disease Control, more than 37 million Americans suffer from a migraine. It is reportedly the leading cause of disability among many other neurological disorders. The United States spends close to $78 billion as direct and indirect costs each year managing the condition.
However, recent surveys indicate that more than 70% of migraine sufferers are not satisfied with their current treatment. Another 80% is ready to try on a new therapy if only it would work faster and with consistency. That said they are hopeful that results from the MOMENTUM study will give AXS-07 superior efficacy making it a better alternative. The expectation is that it will help in lowering symptom recurrence.
The initiation of the CONCERT trial of AXS-12
Within its many projects, Axsome Therapeutics has also picked on a Phase 2 randomized, controlled study of AXS-12. The novel, oral, investigational medicine has received Orphan Drug Designation in the treatment of narcolepsy. However, it is yet to obtain approval from the FDA.
Narcolepsy, which affects approximately 185,000 individuals in the U.S causes dysregulation of the sleep-wake cycle. More often the sufferers experienced excessive daytime sleepiness and disrupted nocturnal sleep. The study will enroll approximately 20 patients. For three week, they will use AXS-12, and another three weeks they will use placebo before the analysis and presentation of results.