IntelGenx and Tetra Bio-Pharma developing dronabinol tablet

By Melissa Fassbender contact

- Last updated on GMT

IntelGenx and Tetra Bio-Pharma developing dronabinol tablet

Related tags: Contract

IntelGenx Corp. and Tetra Bio-Pharma Inc. have signed a binding term sheet for the development and commercialization of a drug product containing dronabinol.

Under the agreement, IntelGenx will be responsible for the research and development of the product, including clinical studies and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa® controlled-release technology, the company told us in a statement.

Next steps are FDA discussion, scale-up of the formulation, and efficacy and safety studies, Edward Miller, Director, IR & Corporate Communications, explained.

Tetra will have exclusive rights to sell the product in North America with a right of first negotiation for outside the US and Canada. The company will make non-refundable exclusive negotiation payment to IntelGenx, an upfront payment, in addition to set milestone payments.

Phase I studies have been completed and showed the mucoadhesive tablet formulation allowed for enhanced bioavailability of the synthetic THC and reduced circulatory levels of 11-OH THC.

These ph I results may translate in 1) increased efficacy and 2) reduced side effects, which remain to be proven clinically​,” Miller said.

(Features image: iStock/utah778)

Related news

Related products

show more

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 15-Jul-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

Empowering Clinical Trial Sponsors with Analytics

Empowering Clinical Trial Sponsors with Analytics

PerkinElmer | 14-Jul-2021 | Technical / White Paper

Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco...

What are the building blocks of DCTs?

What are the building blocks of DCTs?

Medable | 26-Apr-2021 | Technical / White Paper

How to create a seamless experience across eConsent, eCOA and more.

Over the past year, tremendous progress was made toward digitizing and...

Related suppliers

Follow us

Products

View more

Webinars