- Olanzapine (ZYPREXA®) is an antipsychotic medication used to treat schizophrenia and bipolar disorder that is commonly used as anti-nausea off label medication.
- Olanzapine has been investigated for use as an antiemetic at oral doses of
10 mg and 5 mg a day, generally in combination with one or more further agents to treat nausea and vomiting after administration of cisplatin. - STAR-OLZ is being developed for CINV and is ready to enter a Phase 2 clinical trial. STAR-OLZ will be the only product with total control (no nausea, no vomiting, no retching) as a primary indication in CINV.
PARAMUS, N.J., – Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today that the U.S. Patent and Trademark Office (USPTO) granted US Patent # 11,975,112 for “Treatment of Vomiting and Nausea with Minimum Dose of Olanzapine”.
“We are thrilled with the recent granting by the USPTO. This not only strengthens our intellectual property but also validates our continuous delivery platform. Furthermore, it fortifies our position in the industry, empowering us to innovate boldly and drive positive change for patients suffering from nausea,” stated Pedro Lichtinger, Chairman and CEO of Starton Therapeutics.
Olanzapine, an atypical antipsychotic medication primarily used to treat schizophrenia and bipolar disorder, has also shown promise in clinical studies for its effectiveness in managing chemotherapy-induced nausea and vomiting (CINV) when used in combination with standard anti-nausea medications. With side effects such as fatigue and sedation, it is important to identify a minimum effective dose of olanzapine and find improved compositions and methods of delivery, such as transdermal patches, to achieve sustained minimum effective doses and avoid the peaks associated with standard-of-care oral administration.
Olanzapine for prevention of nausea and vomiting has been tested at doses of 10 mg and 5 mg a day, but without a pharmacodynamic evaluation. No studies have evaluated the minimum effective dose in nausea and vomiting. An advantage to transdermal patch delivery is that high and low blood levels are avoided. In the case of most drugs, the maximum concentration (Cmax) is associated with toxicity and the minimum concentration (Cmin) is usually below the required therapeutic blood level.
Starton conducted an exploratory Phase 1 with healthy volunteers to determine the minimal effective dose of olanzapine using transdermal application, followed by a comparative bioavailability study with the optimal formulation compared to the oral olanzapine dose of 10 mg/day. The patent includes claims that the Company’s transdermal application provides administering olanzapine with an AUC (Area Under the Curve) between 20%-80% of the AUC obtained from the standard of care treatment.
The patent has terms extending to 2041, excluding any patent term adjustments or patent term extensions that may provide additional protection. Starton retains full global ownership of the provisional patent applications with the technology and methodology being developed internally. STAR-OLZ has been partnered in China.
About Starton Therapeutics
Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit www.startontx.com.
Forward Looking Statements
All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially from those included within the forward-looking statements.” Readers are cautioned not to place undue reliance on these forward-looking statements, and except as required by law, the Company undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.
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