Clinical Teva to expand into long-acting Schizophrenia injectable medication

Teva to expand into long-acting Schizophrenia injectable medication


The goal that the former CEO of Teva, Kåre Schultz had set in 2021 was to capture 10% of the blockbuster market of schizophrenia drugs. By kicking off a phase 3 trial for its second long-acting schizophrenia drug, Teva is moving one step closer to the dream. The new drug is based on the same depot technology as the prior one which can be credited to MedinCell, Teva’s partner company and French developer of BEPO technology. 

The company’s technology formulates active ingredients that turn into depot after administration of the drug. This depot disintegrates over time and thus, provides the patient with several weeks’ worth of the drug from a single dose.

Teva is evaluating different doses of TV-44749 in this new phase 3 trial. The drug is a monthly formulation of the active ingredient antipsychotic olanzapine which Eli Lilly actually brought to the market in the 1990s. In the trial, 3 doses of TV-44749 and their subsequent effects on symptoms after eight weeks, and long-term effects after 48 weeks were observed for over 600 participants. The end goal is to get the drug candidate to market.

Johnson & Johnson (J&J) and Eli Lilly’s long-acting Schizophrenia therapy injectables entered the market decades ago, and since then paved the path for companies like Luye and Teva to enter the market as well. 

Eli’s similar approval for its long-acting injectable version of olanzapine, Zyprexa Relprevv, for similar disorders encouraged Teva and Luye to step up their respective games. 

While China-based drugmaker Luye was able to secure FDA approval for its drug Rykindo, a risperidone based therapy that uses microsphere technology to extend the gap between intramuscular injections to two weeks. The approval was also granted following a series of clinical trials. 

This approval was also based on two studies that compared its formulation to J&J’s Risperdal Consta which has been leading the market for the past 2 decades. In contrast, Teva was initially knocked down by the agency. Since then, the company has reached near approval for their drug with the depot technology. 

Rykindo can only be administered to adults. 

Although Eli Lilly won approval for its olanzapine-based drug over a decade ago, the company was embroiled in scandal when it became the subject of an inconclusive FDA investigation into the deaths of two patients in the days after dosing. 

Since Teva drug shares the same active ingredient, safety concerns are a key area of focus so that post-injection syndrome, symptoms of which include sedation and delirium. Safety concerns may also in the long run impact the commercial success of the drug. Olanzapine is a serotonin-dopamine-receptor antagonist and iis typically used in the treatment of schizophrenia as well as bipolar disorder.

J&J’s Risperdal Consta, a risperidone formulation for the treatment of schizophrenia is a drug that needs to be administered every two weeks. It has brought the company over $370 million in global sales in the first 9 months of 2022 alone. 

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