Yesterday, Zogenix announced it has initiated its first IND clinical trial for Relday, a product candidate for treating schizophrenia that is based on a combination of the company’s DosePro needle-free, subcutaneous drug delivery system and a proprietary subcutaneous, once-monthly formulation of risperidone. The Relday phase 1 clinical trial is a single-center, open label, safety and pharmacokinetic trial that will enroll 30 patients with chronic, stable schizophrenia, or schizoaffective disorder. The company anticipates the study results will be available by the end of 2012. Additional study information is available at www.clinicaltrials.gov, reference NCT01592110.
Relday represents a significant opportunity for Zogenix to leverage its DosePro system in combination with a novel long-acting formulation of an established antipsychotic, providing psychiatrists and patients with an improved treatment option. The company looks forward to finishing the trial by year’s end, anticipating that discussion can then begin with potential partners for global development and commercialization.
Risperidone is one of the most widely prescribed medications used for treating schizophrenia symptoms in adults and teens 13 and older. The worldwide market for long-acting injectable antipsychotics was around $2 billion last year, with currently approved products that use a 12-gauge or larger needle for intramuscular injections. The current leading product in that category requires twice-monthly dosing and drug reconstitution before use. The combined market for oral and injectable antipsychotics was estimated at more than $16 billion in 2010.
Relday, if approved, will be the first subcutaneous, needle-free antipsychotic product enabling once-monthly dosing. The company believes that Relday will provide an improved pharmacokinetic profile, substantial reduction in injection volume, and a simpler dosing regimen due to DURECT’s (NASDAQ: DRRX) SABER controlled-release depot technology combined with Zogenix’s DosePro needle-free subcutaneous drug delivery system.
Zogenix is a pharmaceutical company specializing in the commercialization and development of products for treating central nervous system disorders and pain. The company’s first commercial product, SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January of 2010 for acute treatment of migraine and cluster headaches. The company’s lead investigational product candidate is Zohydro (hydrocodone bitartrate), which is a novel oral, single-entity (without acetaminophen), extended-release formulation of hydrocodone at various strengths, intended to be administered every 12 hours for around-the-clock management of moderate to severe chronic pain. An NDA was submitted to the FDA for Zohydro in May of 2012. The company’s second DosePro investigational product candidate is Relday – a proprietary, long-acting injectable formulation of risperidone for treating schizophrenia.
For more information, visit the company’s Web site at www.zogenix.com
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