Purdue Pharma 's opioid pain killer not approved by FDA panel
Concerns of overdosing leads to non-approval recommendation by a panel of outside advisors for Purdue Pharma 's opioid drug
Expressing strong concerns on the overdosing of opioid pain killer by Purdue Pharma, a panel of outside advisors from USFDA have recommended not approving it. The agency staff is also worried that the launch of the drug may also trigger the wrong use of a rival opioid pain killer from Collegium Pharmaceuticals.
The fear of overdose of an opioid pain killer is high in the US as an estimated 46 people die everyday in the country merely from opioid painkiller overdose, according to The Centers for Disease Control and Prevention
There have been comments from the FDA's staff in the review meeting on the likely errors in administering the experimental drug. As a result, The FDA panel voted 23 to 1 against the approval.
Purdue Pharma's experimental drug, to be called Avridi on approval, was designed as an abuse-deterrent fast-acting form of opioid painkiller oxycodone, as confirmed by Reuters.
Avridi is among the first few drugs to be evaluated by the FDA for the efficacy of such formulations' abuse-deterrent properties.
Avridi is designed to be taken every 4-6 hours on an empty stomach and the presence of food could cause inadequate pain control. Inadequate pain control could lead to patients taking more of the drug, the FDA staff had said.
Most painkillers can be administered irrespective of food intake.
Expressing strong concerns on the overdosing of opioid pain killer by Purdue Pharma, a panel of outside advisors from USFDA have recommended not approving it. The agency staff is also worried that the launch of the drug may also trigger the wrong use of a rival opioid pain killer from Collegium Pharmaceuticals.
The fear of overdose of an opioid pain killer is high in the US as an estimated 46 people die everyday in the country merely from opioid painkiller overdose, according to The Centers for Disease Control and Prevention
There have been comments from the FDA's staff in the review meeting on the likely errors in administering the experimental drug. As a result, The FDA panel voted 23 to 1 against the approval.
Purdue Pharma's experimental drug, to be called Avridi on approval, was designed as an abuse-deterrent fast-acting form of opioid painkiller oxycodone, as confirmed by Reuters.
Avridi is among the first few drugs to be evaluated by the FDA for the efficacy of such formulations' abuse-deterrent properties.
Avridi is designed to be taken every 4-6 hours on an empty stomach and the presence of food could cause inadequate pain control. Inadequate pain control could lead to patients taking more of the drug, the FDA staff had said.
Most painkillers can be administered irrespective of food intake.
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