Relday® (SABER®-Risperidone)

Overview

Relday is an investigational long-acting, injectable form of the antipsychotic medication risperidone, based on DURECT's proprietary SABER technology.

Zogenix, Inc., our licensee, has stated that Relday could become the first once-monthly subcutaneous antipsychotic product capable of achieving therapeutic drug levels on the first day of administration, eliminating the need for loading-dose regimens at therapy initiation or following missed doses.

Relday has not been approved by the FDA for marketing in the U.S. for any indication.

Relday is being studied for its ability to:

  • Allow once-monthly dosing that could improve patient adherence
  • Be administered by subcutaneous rather than intramuscular injection
  • Achieve therapeutic plasma concentrations on the first day of dosing and steady-state levels following the second dose, which could simplify conversion from oral treatment
  • Provide solution stability without the need for drug reconstitution prior to use

Relday is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.

Schizophrenia is a psychiatric disorder characterized by delusions and hallucinations, disorganized thinking, and abnormal social behavior. Bipolar I disorder is characterized by periods of severely elevated mood (mania) interspersed with episodes of depression. The National Institute of Mental Health (NIMH) estimates the prevalence of schizophrenia and bipolar disorder to be 1.1% and 2.6% of the U.S. adult population (about 2.7 and 6.4 million people), respectively, with bipolar I disorder accounting for roughly half of those with bipolar disorder.

Risperidone is one of the most widely prescribed medications for the treatment of schizophrenia and bipolar I disorder in adults and teenagers. An existing long-acting injectable risperidone product that requires twice-monthly intramuscular injections and drug reconstitution prior to use achieved global net sales of approximately $900 million in 2016.

Relday, an investigational new drug containing risperidone, has not been approved by the FDA for marketing in the U.S. for any indication.

Zogenix has completed both single-dose and multiple-dose Phase 1 clinical trials of Relday, for which top-line results were reported in September 2015. According to Zogenix, Relday demonstrated risperidone plasma concentrations in the therapeutic range on the first day of dosing, steady state levels following the second dose, and consistent therapeutic levels throughout the four-month study period. Zogenix also reported that Relday was generally safe and well-tolerated, with a safety profile consistent with that established for risperidone.

Zogenix has stated that it has initiated efforts to secure a development and commercialization partner for Relday, and that Relday is well-positioned to begin a Phase 3 program once a partner is secured.

Relday is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.

DURECT has licensed the worldwide development and commercialization rights to Zogenix, Inc. For a description of the associated terms, please see Collaborations.

Learn more about SABER technology

There are risks and uncertainties associated with our business. Please see our most recent SEC filings (10-K or 10-Q) for a complete description of these risks and uncertainties, which are incorporated herein by reference.