Medications development for substance-use disorders: contextual influences (dis)incentivizing pharmaceutical-industry positioning

Abstract

Introduction: The significant contribution of substance-use disorders (SUDs) to the global-disease burden and associated unmet medical needs has not engendered a commensurate level of pharma-industry research and development (R&D) for novel SUD therapeutics invention. Analysis of contextual factors shaping this position suggests potential routes toward incentivizing R&D commitment for that purpose.

Areas covered: This article considers multiple primary factors that have consorted to disincentivize pharma industry’s operating in the SUD space: ill-understood pathology; variegated treatments and patient profiles; involved clinical trials; and – with particular reference to SUDs-negative cultural/business stigmas and shallow commercial precedent. Industry incentivization for SUD drug innovation requires progress on several fronts, including: translational experimental data and systems; personalized, holistic SUD treatment approaches; interactions among pharma, nonindustry constituencies, and the medical profession with vested interests in countering negative stereotypes and expanding SUD treatment options; and public–private alliances focused on improving SUD pharmacotherapy.

Expert opinion: Given the well-entrenched business stance whereby the prospect of future profits in major markets largely determines drug-company R&D investment trajectory, strategic initiatives offering substantial reductions in the risks and opportunity (i.e., time and money) costs associated with SUD drug discovery are likely to be the most potent drivers for encouraging mainstream industry positioning in this therapeutic area. Such initiatives could originate from front-loaded R&D operational and back-loaded patent, regulatory, marketing and health-care policy reforms. These may be too involved and protracted for the turbulent pharmaceutical industry to entertain amid its recent retrenchment from psychiatric/CNS diseases and intense pressures to increase productivity and shareholder value.

Keywords::

• abuse potential
• addiction
• CNS
• discovery alliances
• drug development
• economics
• pharmacological intervention
• psychobehavioral illness
• regulatory requirements
• systems biology
• therapeutics discovery

Acknowledgment

The expert bibliographic assistance of Mitchel Ayer is gratefully acknowledged.

Notes

This box summarizes key points contained in the article.