Purdue Pharma will use ElMindA’s Brain Networks Activation (BNA™) technology in a strategic, multiyear research collaboration designed to help develop new and better pain drugs—at a time when FDA is encouraging drug makers to manufacture abuse-resistant opioid medicines.
BNA uses noninvasive recordings of multi-channel EEG event-related potentials and analysis of such recordings by advanced algorithms, aimed at understanding and visualizing the brain networks' activation patterns of brain function, dysfunction, disease progression, and response to therapeutic interventions. Researchers will use BNA to study dynamic functional changes in brain networks pre- and post-drug administration, hoping to reveal mechanisms of action, optimize drug dosages, and identify responders and nonresponders to therapies early in drug development.
The technology will be used in the companies’ staged research collaboration. Purdue Pharma and ElMindA said they will develop objective assessments of analgesia and other subjective responses to treatment, and will include several projects aimed at discovering and developing new clinical diagnostic tests and biomarkers to manage pain and enable development of more effective pain treatments.
Financial terms of the collaboration were not disclosed.
The collaboration with Purdue Pharma—whose products include the pain drug OxyContin (Oxycodone)—marks “an expansion of the company's collaborations with pharma companies and the addition of pain management to the Company's portfolio of therapeutic focus,” ElMindA CEO Ronen Gadot said in a statement.
Purdue Pharma said in the statement its collaboration was an example of the company broadening the scope of its research collaborations beyond drug discovery and development, toward enhancing overall quality of pain management: “Purdue scientists are evaluating potential mapping systems to objectively assess pain, new applications and technologies for pain management, new technologies for controlling drug release, and methods to assess treatment compliance.”
News of the collaboration comes nearly three weeks since FDA issued proposed rules or “draft guidance” designed to promote production of abuse-resistant pain medicines.
“Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling” contains FDA’s perspective on what studies drug makers should conduct to show the agency their medications are abuse-resistant, how those studies will be evaluated, and what labeling claims may be allowed based on study results. Once finalized, the guidance would apply to biopharmas planning to launch new formulations of opioid products.
Purdue Pharma is among drug developers already marketing abuse-resistant formulations of their pain drugs. But the company and other makers of brand-name pain drugs face a competitive challenge, since FDA approved nontamper-resistant generic versions of Endo Pharmaceuticals’ Opana (oxymorphone) before the branded drug’s June 2012 reintroduction with a crush-resistant formulation. FDA has not commented on why the generics have not been asked to make abuse-resistant versions.
Generic versions of Opana ER 7.5 mg and 15 mg are available from Actavis, which is joining several companies this year in planning to launch additional generic versions including Impax, Sandoz, Teva, Watson, Roxane, and Ranbaxy.