AcelRx Pharmaceuticals (Nasdaq: ACRX) has announced that it has received a patent for its Sufentanil Nano Tab system — a new method for treating severe postoperative pain through a patient- controlled analgesia (PCA) device. Sufentanil is a powerful synthetic opioid, used mostly in operating rooms and for critical care.
The Nano Tab system delivers small doses of sufentanil through sublingual tablets delivered via a cartridge. The cartridge is locked inside a pre-programmed, handheld controller that can only be used by the patient. There is a lockout period between doses, so the patient cannot repeat a dose for at least 20 minutes.
In traditional PCA systems, patients control their pain by pushing a button on a computerized pump, which contains a syringe of morphine or hydrocodone connected directly to an intravenous (IV) line.
According to AcelRx,, the Nano Tab system is safer and more effective than infusion pumps, because a more precise dose can be delivered. Overdosing or under dosing with a powerful narcotic can cause severe complications, including sedation, shallow breathing and oxygen desaturation — particularly in older patients.
“This important addition to our patent portfolio strengthens our ability to protect our proprietary technology in theUnited States,” said Richard King, AcelRx’s President and CEO. “We remain focused on continued expansion of our patent portfolio as we establish the safety and efficacy profile of our ARX-01 Sufentanil NanoTab PCA System, with first data from our Phase 3 program for ARX-01 expected later this year.”
Phase I studies of the Sufentanil Nano Tab confirmed that it provides lower peak plasma levels and longer-lasting plasma concentration than IV administration. Phase II studies found a low incidence of sedation.
AcelRx also announced two additional products that have completed Phase II clinical development. They are ARX-02 for the treatment of cancer breakthrough pain, and ARX-03 for mild sedation, anxiety reduction and pain relief for patients undergoing procedures in a physician’s office.