Johnson & Johnson wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J ($JNJ) as well as Alkermes ($ALKS), which provided their NanoCrystal delivery tech for the new-and-improved therapy.
J&J says it's on track to get the 3-month formulation NDA to the FDA later this year.
Neuroscience has proven to be a minefield for drug developers in recent years, but a me-better drug like this could expect to go into a new Phase III with a better formulation holding high odds for success. Alkermes has specialized in developing longer-lasting formulations of drugs for diabetes and neuroscience drugs. The company acquired the NanoCrystal tech when it bought out Elan's drug delivery tech unit for close to a billion dollars three years ago. And it's been working on new-and-improved drugs of its own in this area of R&D.
|Husseini Manji, global therapeutic area head of neuroscience, Janssen|
"We are really excited about this news because a medication's ability to delay time to relapse in schizophrenia has significant clinical and societal implications," said Husseini Manji, who heads up Janssen's neuroscience R&D efforts, in a statement. "Being able to delay relapse can prove to be beneficial clinically to patients, to their caregivers and to the community."
In the study schizophrenic patients were initially stabilized with the one-month formulation of Invega Sustenna (paliperidone palmitate) and then randomized to either a placebo or the three-month formulation as patients were observed on the time interval to their next relapse. The study launched last spring with 509 patients. The international study was wrapped after investigators were able to distinguish a statistically significant difference between the two arms after the first 42 relapses were noted.
- here's the release