Shares of DURECT Corporation (NASDAQ:DRRX) ended Monday session in red amid volatile trading. The shares closed down -0.54 points or -31.76% at $1.16 with 11.38 million shares getting traded. Post opening the session at $1.20, the shares hit an intraday low of $1.08 and an intraday high of $1.22 and the price vacillated in this range throughout the day. The company has a market cap of $155.73 million and the numbers of outstanding shares have been calculated to be 137.41 million shares.
On Sept. 26, 2016 DURECT Corporation (DRRX) announced that its licensee, Pain Therapeutics (PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Pain Therapeutics’ New Drug Application (NDA) for REMOXY® ER (oxycodone) extended-release capsules CII. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.
In a press release issued this morning by Pain Therapeutics, Pain Therapeutics states that “The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.”
The announcement continues that “Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. The CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants.”
Shares of Amarin Corporation plc (ADR) (NASDAQ:AMRN) ended Monday session in green amid volatile trading. The shares closed up +0.18 points or 6.12% at $3.12 with 10.18 million shares getting traded. Post opening the session at $2.94, the shares hit an intraday low of $2.93 and an intraday high of $3.15 and the price vacillated in this range throughout the day. The company has a market cap of $709.42 million and the numbers of outstanding shares have been calculated to be 205.65 million shares.
Amarin Corporation plc (ADR) (AMRN) on Sept. 12, 2016 announced that, as expected, the independent data monitoring committee (DMC) has completed its review of the first pre-specified interim efficacy analysis for the REDUCE-IT cardiovascular outcomes study and has recommended that the trial continue as planned without modification. The 8,175-patient outcomes study is evaluating whether treatment with Vascepa® (icosapent ethyl) reduces cardiovascular events in patients who despite stabilized statin therapy have elevated triglyceride levels and other cardiovascular risk factors.
In accordance with the study protocol, the first interim efficacy analysis was performed after adjudication of approximately 60% of the target 1,612 aggregate primary cardiovascular events occurred within the study. Preparations for a second planned interim efficacy analysis will be triggered by the onset of approximately 80% of the target aggregate number of primary cardiovascular events. Amarin anticipates that the onset of approximately 80% of events will occur in the first half of 2017, with the second pre-specified interim efficacy analysis and review by the DMC expected around mid-2017. Amarin will remain blinded to results of the study until after the study is stopped and the database is locked at either the second interim analysis or at the final analysis.
The DMC’s recommendation to continue as planned also reflects its review of all available safety data. In accordance with the study protocol and DMC charter, safety reviews have been performed multiple times each year since REDUCE-IT began in December 2011, and more than 23,000 patient years of study have been accumulated to date in the ongoing REDUCE-IT study. The review and recommendation of the DMC was made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC’s closed session deliberation.
“We have accepted the independent DMC’s recommendation, and we are pleased that REDUCE-IT continues as planned. We continue to anticipate that accumulation of additional cardiovascular events will add further robustness to the results of this important study which is the first outcomes study ever to evaluate if the addition of pure EPA Vascepa to statin therapy confers a meaningful reduction in the occurrence of major cardiovascular events in patients with persistent elevated triglycerides and other cardiovascular risk factors,” said Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. “We remain confident that the REDUCE-IT study is positioned for success based on our extensive review of existing data from clinical, epidemiologic and genetic studies, and we look forward to the study’s anticipated completion. We continue to expect the onset of the final primary cardiovascular event to occur in the second half of 2017 with the publication of results anticipated in 2018.”