A phase 3 clinical trial for an injection to treat patients with schizophrenia has been initiated after a $3 million payment was received by MedinCell.
Teva Pharmaceuticals made the decision to start the trial for mdc-TJK this week (August 29).
Schizophrenia is a serious mental disorder in which people interpret reality abnormally. Schizophrenia can produce a combination of hallucinations, delusions, and extremely disordered thinking and behavior.
Richard Malamut, Chief Medical Officer at MedinCell: “Efficacy, safety, and tolerability of our formulation of olanzapine will be assessed during the phase 3 study conducted by our partner.
“I believe that our subcutaneous, long-acting injection technology will demonstrate strong efficacy that supports use of this drug in more difficult to treat patients with schizophrenia as well as an improved safety profile.
“Approved intramuscular formulations of long-acting injectable olanzapine require the healthcare professional to continuously observe the patient for at least 3 hours after each injection. This is currently a real barrier to a broad use of olanzapine’s LAIs by clinicians.”
First subcutaneous injectable
The study will assess the efficacy and safety of what could be the first subcutaneous long-acting injectable formulation of olanzapine.
Based on MedinCell’s technology, the antipsychotic is currently undergoing review by the U.S Food and Drug Administration (FDA) with a launch target set for 2023.
Christophe Douat, CEO of MedinCell: “Teva has decided to invest heavily in this second joint program by starting its phase 3 clinical study. It is a huge sign of confidence of our partner after the complete response letter the first program using our technology received recently.
“And all the more that with this second product Teva now intends to succeed where Eli Lilly did not. There is a very strong need for an easy-to-use long-acting injectable of olanzapine. The potential in the US and worldwide is huge and could allow for a substantial growth of the long-acting injectable antipsychotics market.”
In 2012, Eli Lilly and Co announced it was stopping the development of an experimental schizophrenia drug after a recent analysis showed that a late-stage trial on the drug was likely to fail.