The company said rapastinel will not likely hit primary and secondary endpoints in three acute studies based on data from an interim analysis.
Allergan’s late-stage adjunctive treatment for major depressive disorder failed to distinguish itself against placebo. The company said rapastinel will not likely hit primary and secondary endpoints in three acute studies based on data from an interim analysis.
The announcement about rapastinel came one day after Johnson & Johnson won regulatory approval for its esketamine-based nasal spray for MDD. David Nicholson, head of research and development at Allergan, said the company is “deeply disappointed” in the results from the three studies. He said the failure is a “vivid reminder” of how challenging drug development is, particularly in the field of mental health. Nicholson said the company remains committed to developing “new life-changing medications” to fight the rising toll of mental illness. He said Allergan will evaluate the data from the three studies and make a decision on their future later this year. Detailed results from these three studies will be presented at future scientific meetings, Allergan said.
The three Phase III trials assessed the efficacy, safety and tolerability of rapastinel, compared to placebo, both in combination with antidepressant therapy (ADT) in patients with MDD who had a partial response to ADT. In all three pivotal clinical trials rapastinel was well tolerated and demonstrated a safety and tolerability profile similar to placebo, Allergan said.
Rapastinel is a modest and selective positive NMDA receptor that has a “unique pharmacological mechanism of action fundamentally different from ketamine,” Allergan said. In a previously conducted Phase II clinical study rapastinel demonstrated a rapid onset of antidepressant effect within one day, which continued for approximately seven days after a single injection. Allergan acquired rapastinel through its deal for Naurex.
Patients who participated in the three rapastinel studies were ages 18 to 65 and met certain criteria for MDD. The participants who participated had to have had a current major depressive episode of at least eight weeks and not exceeding 18 months in duration. Additionally, eligible patients had to have had experienced no more than a partial response to ongoing treatment with antidepressant therapies. Patients were required to continue their oral ADT throughout the entire study at a stable dose.
MDD affects more than 300 million people across the globe. Depression is listed as the leading cause of disability worldwide and as a major contributor to the overall global burden of disease, according to the World Health Organization. Approximately 16 million Americans are living with MDD, with 6.7 percent of U.S. adults reporting at least one MDD episode in the past year, Allergan said.
Shares of Allergan are down less than 1 percent in premarket trading.
