AcelRx shares surge after FDA staff says opioid safe
With opioid abuse reaching epidemic proportions in the United States, the FDA has been extremely cautious about issuing new approvals and is looking to approve reformulated versions of opioids that are harder to abuse.
The FDA declined to approve the drug - Dsuvia - last October, seeking additional safety data and asking for certain changes in directions of use to ensure that the drug is administered properly.
The drug is a new formulation of the potent opioid sufentanil that is meant to be taken orally through a pre-filled, single-dose applicator for the management of acute pain in patients in a medically supervised setting.
An advisory panel to the FDA will vote on the drug on Friday, before the regulator's final decision by Nov. 3. The regulator generally follows the advice of its experts but is not obliged to do so.
With opioid abuse reaching epidemic proportions in the United States, the FDA has been extremely cautious about issuing new approvals and is looking to approve reformulated versions of opioids that are harder to abuse.
The FDA, however, said the small tablet size of AcelRx's drug has the risk of being dropped or misplaced during administration, which increases the risk of accidental exposure, overdose, and death, particularly in children.
"We determined that the benefit may outweigh the risk of accidental exposure if sufentanil sublingual tablet 30 mcg is administered by a health care provider only in certified medically supervised settings," FDA staffers said.
The company's shares were up 30 per cent at $3.45 by midday after initially falling in premarket trading following the release of the briefing documents.
"We believe there had been some confusion as the first review cycle information had been included in the package," RBC Capital Markets analyst Randall Stanicky said, adding the language in the staff's review appeared supportive of an approval.
New Delhi: Acel Rx Pharmaceutical Inc shares surged 30 per cent after U.S. Food and Administration staff said the company's opioid treatment was safe and effective, bringing it one step closer to a marketing approval.
The FDA declined to approve the drug - Dsuvia - last October, seeking additional safety data and asking for certain changes in directions of use to ensure that the drug is administered properly.
The drug is a new formulation of the potent opioid sufentanil that is meant to be taken orally through a pre-filled, single-dose applicator for the management of acute pain in patients in a medically supervised setting.
An advisory panel to the FDA will vote on the drug on Friday, before the regulator's final decision by Nov. 3. The regulator generally follows the advice of its experts but is not obliged to do so.
With opioid abuse reaching epidemic proportions in the United States, the FDA has been extremely cautious about issuing new approvals and is looking to approve reformulated versions of opioids that are harder to abuse.
The FDA, however, said the small tablet size of AcelRx's drug has the risk of being dropped or misplaced during administration, which increases the risk of accidental exposure, overdose, and death, particularly in children.
"We determined that the benefit may outweigh the risk of accidental exposure if sufentanil sublingual tablet 30 mcg is administered by a health care provider only in certified medically supervised settings," FDA staffers said.
Oppenheimer analyst Leland Gershell expects the focus of Friday's discussion to be the risks associated with dropped tablets, given their sesame-seed size and high-potency opioid contents.
The company's shares were up 30 per cent at $3.45 by midday after initially falling in premarket trading following the release of the briefing documents.
"We believe there had been some confusion as the first review cycle information had been included in the package," RBC Capital Markets analyst Randall Stanicky said, adding the language in the staff's review appeared supportive of an approval.
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