Bloomberg Business Week
The Food and Drug Administration plans a two-day public hearing starting Feb. 7 after receiving “comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain.” The meeting is intended to help understand how doctors define pain and measures used to limit opioid use, the agency said today in a statement. The balancing act was highlighted two weeks ago when San Diego-based drugmaker Zogenix Inc. (ZGNX) failed to persuade FDA advisers to support approval of the first single-ingredient hydrocodone pill. While the company showed the medicine worked and presented patients from a trial who said the pill filled a need in the market, advisers at the Dec. 7 meeting were swayed by other stories of addiction and death.
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The Food and Drug Administration plans a two-day public hearing starting Feb. 7 after receiving “comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain.” The meeting is intended to help understand how doctors define pain and measures used to limit opioid use, the agency said today in a statement. The balancing act was highlighted two weeks ago when San Diego-based drugmaker Zogenix Inc. (ZGNX) failed to persuade FDA advisers to support approval of the first single-ingredient hydrocodone pill. While the company showed the medicine worked and presented patients from a trial who said the pill filled a need in the market, advisers at the Dec. 7 meeting were swayed by other stories of addiction and death.
