Zogenix Submits IND for Second DosePro(R) Candidate Relday(TM)
Zogenix Inc. (Nasdaq: ZGNX) today announced that it has submitted an investigational new drug (IND) application to the U.S. Food & Drug Administration (FDA) for Relday™, which is a combination of Zogenix's DosePro® needle-free, subcutaneous drug delivery system plus a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. In July 2011, Zogenix licensed from DURECT (Nasdaq: DRRX) exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT's SABER® depot technology. Initial clinical trials are currently planned to begin in the second half of the year, with results expected by year-end.
Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia in adults and teenagers 13 years of age and older. The global long-acting injectable antipsychotic market was approximately $2 billion in 2011, with currently approved products using a 21-gauge or larger needle for intramuscular injections. The leading product in the category requires twice-a-month dosing and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $16 billion in 2010.
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