Teva Pharmaceutical has opened another front in its expansion into long-acting injectables, kicking off a phase 3 clinical trial of a prospect based on the same technology as its near-approval schizophrenia drug.
The candidate is the latest product of Teva’s collaboration with MedinCell, the French developer of BEPO technology for extending the release of injectable therapies. Using the technology, MedinCell formulates active ingredients so they turn into a depot after administration. The depot breaks down over time and therefore provides the patient with several weeks' worth of the drug from a single dose.
In the new phase 3 trial, Teva is evaluating different doses of TV-44749, a monthly formulation of the antipsychotic olanzapine. The active ingredient, which Eli Lilly brought to market as Zyprexa in the 1990s, is a serotonin-dopamine-receptor antagonist that is used to treat schizophrenia and bipolar disorder.
Teva is betting that there is a market for a long-acting injectable formulation of the ingredient. To get the candidate to market, the drugmaker has begun a phase 3 trial that will compare three doses of TV-44749 to placebo in 640 adults with schizophrenia. The primary endpoint is looking at the effect on symptoms after eight weeks, and a long-term follow-up period is tracking participants for 48 weeks.
Safety will be a key area of focus. Lilly won approval for a long-acting injectable version of olanzapine, Zyprexa Relprevv, more than a decade ago. But the product, which can cause post-injection syndrome, symptoms of which include sedation and delirium, made a slow start commercially and was then the subject of an inconclusive FDA investigation into the deaths of two patients in the days after dosing.
Teva’s own long-acting injectable olanzapine is advancing down the pipeline in the wake of its initial move into the space, a formulation of risperidone that was knocked back by the FDA at the first time of asking but is now the subject of a fresh filing for approval.