FDA Approves New Version of Oxycodone
/By Pat Anson, Editor
The U.S. Food and Drug Administration has approved a new extended released version of the opioid painkiller oxycodone that has abuse deterrent properties unlike anything else on the market.
The drug – called Xtampza – can be ingested in capsule form, but users can also sprinkle the capsule contents on soft foods or into a cup, and then directly into the mouth.
The medication, which can also be ingested through a feeding tube, is the sixth opioid pain medication with an abuse deterrent formula to be approved by the FDA.
Xtampza is made by Massachusetts-based Collegium Pharmaceutical (NASDAQ: COLL) with proprietary technology that combines oxycodone with fatty acid and waxes to form small spherical beads that are placed inside the capsule.
The beads are designed to resist breaking, crushing, chewing, dissolving and melting, methods long used by drugs abusers to snort or inject opioids.
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That novel approach is different from other abuse deterrent formulas, which generally make it harder for tablets to be crushed or liquefied; or come with a chemical irritant to discourage tampering.
“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids,” said Michael Heffernan, CEO of Collegium.
Another advantage of Xtampza is that it gives an alternative to patients who have trouble swallowing tablets or capsules, a condition know as dysphagia.
"People like me live with dysphagia that prevents us from swallowing normally all the time. Up until this new drug coming out, people not able to swallow have had to rely on liquids and patches for relief - not being able to take their oxycodone," said PNN columnist Ellen Lenox Smith, who suffers from Ehlers Danlos syndrome and sarcoidosis. She testified in favor of Xtampza's approval for the U.S. Pain Foundation.
"Although this is a medication not compatible to my body, I testified on it's behalf for those people around the country not able to take their medications and thus not getting the relief they deserve. I am thrilled that this got approved so soon and that people will have this as an option and hope that this safer formula will help to calm the nerves of all the people out there concerned about addiction to opiates," Smith said.
“Xtampza ER also allows for flexible dosing administration for patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be very dangerous with currently marketed ER products,” said Dr. Jeffrey Gudin, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center.
Xtampza, which is designed to be taken twice a day by patients who need around-the-clock pain relief, comes with an FDA warning to take the medication with food. Taking it on an empty stomach could lead to inadequate pain control.
Collegium plans to launch Xtampza ER in the U.S. in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone.
