Johnson & Johnson
) halted an early phase III study (n=509) on a three-month
formulation of Invega Sustenna (paliperidone palmitate) on
recommendation of an Independent Data Monitoring Committee
(IDMC). The IDMC also recommended Johnson & Johnson to
unblind data from the study based on certain positive efficacy
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The international, randomized, multicenter, double-blind study
was evaluating the efficacy of the three-month formulation of
Invega Sustenna in delaying time to first occurrence of relapse
of symptoms of schizophrenia in adults compared to placebo. The
patients in the study were initially randomized with the
one-month formulation of Invega Sustenna after which they
received the three-month formulation.
We note that the one-month formulation of Invega Sustenna is
already approved for the treatment of schizophrenia. The
one-month formulation utilizes
) proprietary NanoCrystal technology enabling solubility of
poorly water-soluble compounds.
The IDMC's recommendation was based on certain pre-specified
criteria from the phase III study. Invega Sustenna achieved a
statistically significant difference in delaying time to relapse
based on the interim analysis after 60% (42 events) of the
projected relapses occurred compared to placebo.
Johnson & Johnson intends to file a New Drug Application
(NDA) in the U.S. for the three-month formulation of Invega
Sustenna by year end following final analysis of the study
results and discussions with the U.S. regulatory body.
We note that Johnson & Johnson is already well established in
the schizophrenia market with products like the one-month
formulation of Invega Sustenna and Risperdal Consta. The products
together contributed around $2.6 billion in 2013. In the event of
the three-month formulation of Invega Sustenna getting approved,
Johnson & Johnson will strengthen its position in the market
Johnson & Johnson currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks include
Gilead Sciences Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).