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January 3, 2013
07:41 EDTZGNXZogenix reports positive results from Relday Phase 1 clinical trial
Zogenix announced positive single-dose pharmacokinetic, or PK, 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. Adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. Based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the current study to include a 100 mg dose of the same formulation. The addition of this dose arm to the study will enable evaluation of dose proportionality across the full dose range that would be anticipated to be used in clinical practice. Positive results from this study extension would better position Zogenix to begin a multi-dose clinical trial, which would provide the required steady-state PK and safety data prior to initiating Phase 3 development studies. Zogenix expects to complete the extension of the Phase 1 clinical trial during Q2.
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July 14, 2014
08:36 EDTZGNXZogenix announces patent for DosePro Needle-free Delivery System
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July 9, 2014
08:33 EDTZGNXZogenix reports positive development on U.S. District Court ruling
Zogenix commented on the order issued by the U.S. District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to Zohydro ER Extended-Release Capsules, CII, violates Constitutional law. The court's decision supports the importance of upholding the principle at the heart of this case, which is that the FDA is the only regulatory body that is authorized to determine the approval and access of medicines for all Americans. On October 25, 2013, the FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, and today's decision preserves access for those in Massachusetts who may benefit from its medical attributes and sets a precedent for other states seeking to unjustly restrict access to Zohydro ER. Zogenix will continue to work to ensure patients have access to Zohydro ER in every state in a manner that is consistent with all extended-release opioids.
July 8, 2014
14:15 EDTZGNXZogenix motion in suit with Massachusetts allowed in part, denied in part
A judge in the U.S. district court for Massachusetts allowed in part and denied in part Zogenix's motions in its battle with the state over regulations that Massachusetts is seeking to impose on the sales of its pain drug, Zohydro ER. The judge ruled that the company has stated a plausible claim for relief and the state's motion to dismiss was denied without prejudice. The company's motion to preliminarily enjoin the “LMN regulation” was allowed, but Zogenix has not met its burden of proof on the “pharmacist-only regulation” and its motion for a preliminary injunction on that regulation was denied without prejudice to renewal upon a more detailed submission, the judge wrote in the ruling. Note that shares of Zogenix remain down about 9% in afternoon trading, after its competitor, Purdue Pharma, announced earlier today that the FDA has granted Priority Review designation for its once-daily, single-entity hydrocodone bitartrate tablet, which competes with Zohydro ER. Reference Link
13:48 EDTZGNXZogenix drops 10% after competitor gets Priority Review
Shares of Zogenix (ZGNX) are moving lower after Purdue Pharma announced earlier today that the FDA has granted Priority Review designation for its once-daily, single-entity hydrocodone bitartrate tablet. The investigational pain medication was formulated to incorporate abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse, Purdue stated. Shares of Zogenix, which has a competing pain killer drug called Zohydro ER without abuse-deterrent properties, are down 10%, or 22c, to $1.91 in afternoon trading.

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