WALTHAM, Mass., May 30, 2015 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced the successful completion of the rolapitant bioequivalence study.
"The results of this study indicate that the exposure for a 185 milligram dose of intravenous rolapitant is similar to the exposure of a 200 milligram dose of oral rolapitant, said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "By developing two formulations of rolapitant, we may enable oncologists to tailor their antiemetic regimen to best meet the needs of their patients and target the entire CINV market opportunity. We continue to expect to submit the New Drug Application for the intravenous formulation of rolapitant following the commercial launch of oral rolapitant."
This open-label study enrolled healthy male and female volunteers. Study participants were randomized to receive a single dose of either 185 milligrams of intravenous rolapitant administered over 30 minutes (n=61) or 200 milligrams of oral rolapitant (n=62). The primary endpoint of this pivotal study was bioequivalence, defined by estimating whether the 90% confidence intervals (CI) for the ratio of the area under the curves (AUCs) of the two formulations are entirely included within the acceptance range of 80% to 125%. Safety and tolerability were also assessed for both formulations. No new adverse events were identified, and the safety profile was consistent with previous clinical trials of rolapitant.
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions, as well as other words or expressions referencing future events, conditions or circumstances, are intended to identify forward-looking statements. Examples of forward looking statements contained in this press release include, among others, our plans to develop both oral and intravenous formulations of rolapitant, the timing of submission of a New Drug Application (NDA) for IV rolapitant, and the commercial launch of oral rolapitant. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the execution and completion of bioequivalence and clinical trials, ongoing discussions with and actions by regulatory authorities, and other matters that could affect the availability or commercial potential of either oral or IV formulations of rolapitant. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Annual Report on Form 10-K for the year ended December 31, 2014.
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