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News Breaks
January 3, 2013
07:36 EDTZGNX, DRRXDurect announces positive results from Relday Phase 1 clinical trial
Durect (DRRX) announced that its licensee, Zogenix (ZGNX) reported positive single-dose pharmacokinetic results from the Phase 1 clinical trial of Relday, an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. According to Zogenix, adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products.
News For DRRX;ZGNX From The Last 14 Days
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November 20, 2014
14:26 EDTZGNXZogenix slips after FDA approves new extended-release opioid analgesic
Shares of Zogenix, the maker of Zohydro ER, are lower in afternoon trading after the FDA approved Hysingla ER, another extended-release opioid analgesic. WHAT'S NEW: Earlier, the Food and Drug Administration announced it has approved Hysingla ER, which is an extended-release opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry. Hysingla ER is manufactured by Purdue Pharma. WHAT'S NOTABLE: Janet Woodcock, the director of the Center for Drug Evaluation and Research, stated in a post to the "FDA Voice" blog, that the approval of Hysingla ER marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. In her blog post, Woodcock stated: "While Hysingla ER has the same active ingredient, hydrocodone, as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two." Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not, Woodcock noted. The CDER director also stated that the FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER. PRICE ACTION: In afternoon trading, shares of Zogenix slipped 1.7% to $1.18.
November 11, 2014
16:09 EDTDRRXDURECT provides update on FDA communication over POSIDUR
DURECT announced that it has received meeting minutes from its face-to-face meeting with the FDA on September 23, regarding the POSIDUR program. In the February Complete Response Letter, the FDA indicated that multiple safety trials would be required to support a broad indication. DURECT inquired whether it would be possible to expedite approval by pursuing an initial indication of soft tissue post-surgical analgesia without conducting additional trials. The company said the FDA has indicated that in this scenario, it should be acceptable to conduct only one additional soft tissue clinical trial, the size of which is not yet defined, to generate the data required for product approval, including safety data for POSIDUR compared to a non-SABER containing comparator and also product efficacy. "Based on the Complete Response Letter we anticipated that we would be required to do additional safety trials," stated James Brown, President and CEO of DURECT. "Over the coming months, we expect to have further communications with the FDA to refine the path forward."

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