The US FDA has granted priority review status to Johnson & Johnson’s paliperidone palmitate depot, which if approved will become the first schizophrenia drug that can be administered just four times a year.
The current formulation of paliperidone – sold as Invega Sustenna in the US and Xeplion in Europe since 2009 – is given once-a-month to treat schizophrenia and bipolar disorder and has sales of $1.2bn in the first nine months of 2014, a 30% increase on the prior-year period.
Priority review designation means the FDA will review the application in six rather than 10 months, meaning the new formulation could be ready for marketing by the middle of 2015.
The new formulation could provide “an unprecedented treatment option to help address the needs of people living with schizophrenia by providing a new, less frequently dosed treatment choice,” said Husseini Manji, who heads neuroscience R&D at J&J’s Janssen unit.
“New treatments give patients, and caregivers, a broader range of options to address their needs as early as possible in their recovery journeys,” he added.
The reduced dosing frequency could also give the franchise a competitive advantage over once-monthly rivals such as Lilly’s Zypadhera (olanzapine) and Lundbeck’s Abilify Maintena (aripiprazole), which was launched in Europe last year.
Decision Resources has predicted that the three-monthly formulation of paliperidone will be one of the main derivers for growth in the schizophrenia market, which is predicted to grow from $5.9bn in 2013 to $6.4bn in 2017 on the back of new product launches.
After 2017, the overall value of the market is expected to fall back as generic versions of some of the newer antipsychotic depots – including Invega Sustenna, start to reach the market.
Other new products expected to push the market include Alkermes’ once-monthly depot formulation of aripiprazole lauroxil, which was filed for approval in the US last October and could be approved in the summer, as well as two novel antipsychotics – Otsuka/Lundbeck’s brexpiprazole and cariprazine from Actavis and Gedeon Richter.
Cariprazine was turned down by the FDA towards the end of 2013 but has just shown activity in a new phase III trial, cutting the risk of relapse in patients with schizophrenia by 55% versus placebo.
Alkermes’ drug delivery technology is used in the J&J’s three-monthly formulation of paliperidone, and the company also has a longer-acting version of aripiprazole lauroxil in early development.