Potential Utility of LAT8881: Neuropathic Pain

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hronic neuropathic pain remains a clinical area with high unmet need due to several factors. Including a relative lack of investment in new pain drugs by biotech and pharma; Clinical failures/delays due to safety issues in humans (anti-NGF) or failure to demonstrate efficacy in trials with the overall lower success rate for pain drugs transitioning from Phase 1 to Approval of 2% compared to average for all drugs of 9.6%; and  the highly publicized safety and misuse concerns with opioids and more recently with gabapentinoids.

The extent of the opioid and gabapentinoid crises is outlined by the following statistics:

  • 80% of heroin users report misusing prescription opioids prior to heroin (NIH, 2019)
  • 11.1 million Americans are estimated to have past-year misuse/abuse of prescription opioids (FDA, 2019)
  • 130+ people a day die from opioid-related drug overdoses in the U.S. (NIH, 2019)
  • The total “economic burden” of prescription opioid misuse alone in the US is estimated to be USD$78.5 Billion in healthcare, law enforcement and lost productivity (NIH, 2017)
  • In 2017, 47,600 Americans died because of opioid overdose (Centers for Disease Control and Prevention, 2018)
  • In UK  from 2006-2016 prescriptions of gabapentin have risen fivefold, from 1 million to 6.5 million, while those for pregabalin, have risen tenfold (Waters, 2017)
  • GABA drugs are also being prescribed for pain they’re not actually licensed to treat, such as arthritis or lower back pain (Waters, 2017)
  • gabapentin and pregabalin use in non-neuropathic pain disorders indicates they are less effective than several other licensed non-opioid analgesics (Morrison, Sandilands & Webb, 2017)
  • There is a significant illicit market for these controlled drugs, which are known to ‘potentiate’ or enhance the effects of opioids (Peckham, Ananickal & Sclar,  2018)

Figure 1 U.S drug overdose deaths involving any opioid, 1999-2017 (Center for Disease Control and Prevention, 2018)

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The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act – October 2018 is aimed at addressing the opioid overdose epidemic in the United States. It includes provisions to educate the population about addiction medicine, standardize the delivery of addiction medicine and cover addiction medicine in a way that facilitates the delivery of coordinated and comprehensive treatment. It also outlines the need for a safe, effective, non-addictive treatments to manage chronic pain (FDA, 2019).

Policy change in the U.S. raises the possibility of collaborative research studies with the NIH through the HEAL initiative, and FDA expedited pathways. Lateral could pursue:

  • various partnerships and collaboration opportunities with the NIH
  • NIH grant opportunities
  • Breakthrough Therapy Designation with the FDA
  • FDA Accelerated Approval
  • FDA Fast Track
  • FDA Priority Review
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References

Centers for Disease Control and Prevention. (2018). “National Drug Overdose Deaths Number Among All Ages, by Gender, 1999-2017.” National Institute of Health. Retrieved on the 13th of May 2019 from https://www.drugabuse.gov/related-topics/trends-statistics/overdose   death-rates

Gottlieb, S. (2018). “Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.” U.S. Food & Drug Administration (FDA). Retrieved on the 13th of May 2019 from https://www.fda.gov/news-events/press announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-ongoing-work-forcefully-address-opioid-crisis

Morrison, E.E., Sandilands, E.A., & Webb, D.J. (2017). “Gabapentin and pregabalin: do the benefits outweigh the harms?” J R Coll Physicians Edinb, 47(4), 310-313. doi:10.4997/JRCPE.2017.402

National Instutute on Drug Abuse. (2019). “Opioid Overdose Crisis.” National Institute of Health.  Retrieved on the 13th of May 2019 from https://www.drugabuse.gov/drugs abuse/opioids/opioid-overdose-crisis

Peckham, A.M., Ananickal, M.J., & Sclar, D.A. (2018). “Gabapentin use, abuse, and the US opioid epidemic: the case for reclassification as a controlled substance and the need for pharmacovigilance.” Risk Manag Healthc Policy, 11, 109-116. doi:10.2147/RMHP.S168504

Thomas, D., & Wessel, D. (2018). “Volume II: Pain and Addiction Therapeutics.” The State of Innovation in Highly Prevalent Chronic Diseases. Biotechnology Innovation Organization. Retrieved on the 13th May 2019 from https://www.bio.org/sites/default/files/BIO_HPCP_Series-Pain_Addiction_2018-02-08.pdf

Waters, J. (2017). “The crippling toll of the new Valium that’s ruining the lives of MILLIONS: Rapid rise in prescriptions for GABA drugs is worrying experts.” Daily Mail Australia. Retrieved on 13 May 2019 from https://www.dailymail.co.uk/health/article-5102355/Crippling-toll-new-valium-ruining-lives-MILLIONS.html