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Nov 19, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Relistor methylnaltrexone regulatory update

Salix disclosed in its 3Q12 earnings that FDA indicated it will require "a very large, well-controlled, chronic administration trial" to assess the safety of subcutaneous Relistor methylnaltrexone prior to approval for the treatment of opioid-induced constipation (OIC) in patients with non-cancer pain. FDA communicated the request during an October end-of-review meeting with the...

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