US FDA OKs new painkiller for cancer patients – Onsolis an Opiod Drug
Posted Jul 16 2009 11:05pm
Patients need to already be using an opioid pain medication around the clock. I thought these types of drugs were being scrutinized, but ok that cancer patients who need the relief can still get it. The medicine will be sent directly to a patient’s home though? Hopefully it may be return receipt requested as this is a heavily controlled substance so others do not take it from those who really need it. Providers and pharmacies will both need to be enrolled in a training program in order to prescribe and availability should be in the 4th quarter. BD
* Distribution will be restricted to prevent misuse - FDA
WASHINGTON, July 16 (Reuters) - U.S. health officials approved a new opioid drug to relieve severe flare-ups of pain that occur in cancer patients despite treatment with other pain medications.
The drug, called Onsolis, is made by Aveva Drug Delivery Systems and marketed by Meda AB ( MEDAa.ST ) under a license from BioDelivery Sciences International Inc ( BDSI.O ), the Food and Drug Administration said on Thursday.
For patients who are not opioid tolerant, Onsolis "can lead to overdose, sudden serious breathing difficulties and death," Bob Rappaport, head of the FDA division that reviewed the drug, said in a statement.