Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ALKS 5461, an oral, once-daily investigational medicine with a new action mechanism for adjunctive treatment of major depressive disorder (MDD).
The company submitted NDA based on clinical efficacy and safety aspects with data drawn from more than 30 clinical trials and more than 1,500 patients suffering with MDD.
During the clinical development programme, ALKS 5461 showed a consistent profile of antidepressant activity, safety and tolerability.
FDA granted ALKS 5461 with fast-track status in October 2013 for the adjunctive treatment of MDD in patients who did not adequately respond to standard antidepressant therapies.
Alkermes research and development executive vice president Elliot Ehrich said: “ALKS 5461 represents the first potential treatment option with a novel mechanism of action for the treatment of depression in 30 years.
“We believe its unique pharmacology may provide distinct clinical benefits for the large number of patients who do not get adequate relief from first-line standard antidepressant therapy.
“With this regulatory submission, we are one step closer to our goal of bringing this important new medicine to patients, families and healthcare professionals, who are eager for new treatment options.”
Alkermes clinical development and medical affairs chief medical officer and senior vice president Craig Hopkinson said: “ALKS 5461 has demonstrated consistent safety, tolerability and antidepressant activity for the adjunctive treatment of major depressive disorder throughout its comprehensive clinical development programme.
“The NDA submission of ALKS 5461 further demonstrates our ongoing commitment to developing innovative, patient-centred treatment options for those afflicted by serious mental illness and chronic CNS disorders.”
Serving as an opioid system modulator, ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
It is estimated that 17 million people in the US suffer from MDD, most of whom may not sufficiently respond to initial antidepressant therapy.