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Tetra Bio Pharma Inc (OTCQB:TBPMF) Anticipates To Commercialize ‘Dronabinol XL’ Tablet Ahead of Schedule In the U.S.

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Tetra Bio Pharma Inc (OTCQB:TBPMF) reported that it is associating with a key manufacturer of controlled APIs in the U.S. for the production of Dronabinol XL AdVersa® as the firm ramps up its plans to file a 505(b)(2) NDA for the treatment of CINV and anorexia related with weight loss in people with AIDS.

The details

As per a market research, the international chemotherapy-induced nausea and vomiting market will touch a valuation of $1.88 billion by 2020, up from its 2013 worth of $1.28 billion. Grounded on the projected enhanced safety profile of a DR Dronabinol, Tetra Bio project that the Adversa® tablet can record a notable share of this market within 3 years of its release in the United States, with sales of Adversa® that is projected to hit $30 million at the close of the third year of sales.

Earlier in March, Tetra got the Dronabinol XL Adversa® know-how from IntelGenx and finalized a co-development deal to get this controlled release formulation of tetrahydrocannabinol to the market. The company is seeking to boost its commercialization plans in the United States by seeking marketing nod by the Food and Drug Administration for the different therapeutic indications, which are similar to those of Marinol®.

Use in curing anorexia related with weight loss in people with AIDS, and vomiting and nausea associated with cancer chemotherapy in people who have failed to respond sufficiently to conventional antiemetic treatments. It’s buccal management in instances of nausea makes it a remarkable attractive therapeutic alternative for cancer patients.

Tetra’s association with a key manufacturer in the United States that has been producing dronabinol for years to advance the commercial manufacturing of this patent-protected new drug is important in its filing to the FDA. The NDA submission under 505(b)(2) to the U.S. FDA needs demonstration that the formulation offers similar systemic exposure to the approved/listed drug dronabinol.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of MMJReporter.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure

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