Purdue Pharma Partners with ElmindA in New Drug Discovery
Purdue Pharma will ElmindA’s BNA technology in a research partnership to help build better pain medication, to accommodate the FDA’s push for safer, less abusive opioid drugs.
Brain Networks Activation (BNA) uses noninvasive copies of multi-channel EEG event related potentials and data of such recordings by advanced alogrithms, aimed at understanding and visualizing the BNA patterns of brain function, disease progression, response to medicines and brain dysfunction. Scientists will use BNA to study dynamic functional changes in BNA for pre and post drug administration, hoping to unveil the workings of medicines which will help optimize drug dosages and identify responders and non-responders 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 determining and developing new clinical diagnostic tests and biomarkers to manage pain and enable improvement of more effective pain treatments. Financial terms of the collaboration were not disclosed.
The partnership with Purdue Pharma—whose products include the pain drug OxyContin (Oxycodone)—marks “a growth of the company’s alliances 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 possible mapping systems to objectively assess pain, new applications and technologies for pain management, new technologies for monitoring drug release, and methods to assess treatment compliance.”
News of the alliance comes nearly three weeks since FDA issued proposed rules or “draft guidance” designed to promote production of abuse-resistant pain medicines.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 viewpoint 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 scheduling to launch new formulations of opioid products.
Purdue Pharma is among drug developers already marketing abuse-resistant designs 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 mentioned 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 basic versions including Impax, Sandoz, Teva, Watson, Roxane, and Ranbaxy.
