Heron discloses new IV formulation of NK-1 receptor antagonist to prevent CINV

NK1 receptor antagonists are administered in combination with a 5-HT3 receptor antagonist for the prevention of CINV. Heron Therapeutics’ lead investigational product candidate, SUSTOL® (granisetron injection, extended release), is an extended release 5-HT3 receptor antagonist being developed for the prevention of both acute- and delayed-onset CINV.

Heron Therapeutics’ new investigational product candidate HTX-019 is a proprietary intravenous (IV) formulation of aprepitant, an NK1 receptor antagonist. The HTX-019 formulation is distinguishable from the only IV NK1 receptor antagonist presently approved for the prevention of CINV in the U.S. in that it does not contain polysorbate 80, which may cause hypersensitivity reactions in some patients.

Registration of HTX-019 is expected to use the 505(b)(2) regulatory approval pathway for new drug applications filed with the U.S. Food and Drug Administration (FDA), with potential commercial launch in 2016.

"The addition of a differentiated IV administrable NK1 receptor antagonist to our growing CINV franchise will help us to build a potentially dominant position in this segment of the oncology supportive care market, which is estimated to be greater than $500 million per year in the U.S. and potentially over $1 billion worldwide," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics.

Dr. Quart continued, "In addition, we are close to completing our ongoing Phase 3 clinical study of SUSTOL in combination with EMEND, designed to expand the potential indications for SUSTOL to include the treatment of delayed-onset CINV after HEC. No presently approved 5-HT3 antagonist is indicated for delayed-onset CINV in HEC. We anticipate completing enrollment in first quarter of 2015, with the resubmission of the new drug application (NDA) for SUSTOL quickly thereafter."