Last week, the FDA announced a new Risk Evaluation and Mitigation Strategy for transmucosal fentanyl products that places the same regulations on BioDelivery Sciences International's Pain Relief Patch Onsolis as on other similar drugs, according to a news release.
The earlier REMS program required physicians and patients to register and be educated before the drug could be prescribed. Onsolis was the first transmucosal fentanyl required to be regulated under the strategy in 2009.
"BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product," said Mark A. Sirgo, MD, president and CEO of BDSI, in the release. "Unfortunately, companies with similar products being marketed prior to the approval of Onsolis were not all held to the same standard. This resulted in a significant commercial disadvantage for Onsolis given the requirements of the REMS and the associated additional steps required by healthcare providers and their patients."
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"BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product," said Mark A. Sirgo, MD, president and CEO of BDSI, in the release. "Unfortunately, companies with similar products being marketed prior to the approval of Onsolis were not all held to the same standard. This resulted in a significant commercial disadvantage for Onsolis given the requirements of the REMS and the associated additional steps required by healthcare providers and their patients."
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