PALO ALTO, Calif., July 29, 2013 /PRNewswire/ -- Signature Therapeutics, Inc., a development-stage biopharmaceutical company, announced today that it has received no-cost access to contractor resources through the National Center for Advancing Translational Sciences' Bridging Interventional Development Gaps (BrIDGs) program (part of the NIH) to support development of its extended-release, abuse-deterrent oxycodone, PF614 – a novel, inactive prodrug formulation that must be digested to achieve therapeutic benefit. NIH's National Institute on Drug Abuse is providing funding directly to BrIDGs to support the project, which includes scale-up synthesis, drug product packaging, pharmacokinetic analysis and IND-enabling toxicology studies.
Wes Sterman, President and CEO of Signature Therapeutics, commented, "We are grateful to the staff of NIDA and NCATS that saw the value of our abuse-deterrent prodrug technology and which made the decision to provide contractor resources to further our work. Their support helps validate the importance of the prodrug technology approach in the field of abuse-deterrent opioid drugs, and the potential of the technology to greatly impact the public health crisis of prescription drug abuse. We look forward to the continued development of PF614, and anticipate the filing of a US IND in the first half of 2014."
About Prescription Drug Abuse
Abuse of prescription drugs is the fastest growing drug problem according to the US Office of National Drug Control Policy (ONDCP).1 The Centers for Disease Control (CDC) has characterized this problem as an epidemic in the United States.2 More Americans die from overdose of prescription pain killers than from abuse of heroin and cocaine combined, reaching approximately 17,000 deaths per year.3,4 The healthcare costs of prescription drug abuse exceed $72 billion per year in the US.5
PF614 is a prodrug of the opioid drug oxycodone that is designed to create substantial hurdles to both oral and non-oral routes of abuse. Typical methods of abuse of prescription opioid drugs include inhaling or injecting crushed pills or chewing intact pills. Current efforts to thwart these modes of abuse, involving improved tablet-formulation technology to make tablets harder to crush and the opioid drug harder to remove from the tablet, provide some increased level of abuse-resistance. However, Signature Therapeutics' prodrug technology involves creating new molecules that provide very high levels of abuse-resistance based upon the design of the molecules themselves. PF614 is a novel molecule that is designed to release the opioid drug oxycodone only upon its digestion in the patient's small bowel. It is essentially inert when inhaled or injected, resistant to chemical manipulation outside of the body, and completely resistant to release of oxycodone upon chewing.
About Signature Therapeutics
Signature Therapeutics, Inc., is a development-stage biopharmaceutical company located in Palo Alto, California. The Company focuses on the discovery and development of a portfolio of novel chemical entities for the potential treatment of neurological disorders.
1. Epidemic: Responding to America's Prescription Drug Abuse Crisis, OFFICE OF NATIONAL DRUG CONTROL POLICY (2011), available at http://www.whitehouse.gov/sites/default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan_0.pdf.
2. Leonard Paulozzi, et al., CDC Grand Rounds: Prescription Drug Overdoses—A U.S. Epidemic, CENTERS FOR DISEASE CONTROL AND PREVENTION, Jan. 13, 2012, available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm.
3. LEONARD PAULOZZI, supra Note 2.
4. Press Release, Centers for Disease Control and Prevention, Opioids Drive Continued Increase in Drug Overdose Deaths (Feb. 20, 2013), available at http://www.cdc.gov/media/releases/2013/p0220_drug_overdose_deaths.html
5. See Prescription Drug Abuse and Overdose: Public Health Perspective, CENTERS FOR DISEASE CONTROL AND PREVENTION, Oct. 24, 2012, available at http://www.cdc.gov/primarycare/materials/opoidabuse/docs/pda-phperspective-508.pdf.
SOURCE Signature Therapeutics, Inc.