AcelRx Pharmaceuticals, Inc. announced that it has initiated a Shape 2 clinical adversity of ARX-02, a proprietary sublingual sufentanil NanoTab(TM) effect aspirant for cancer breakthrough bore button. The primary objective of this multicenter, randomized, placebo-controlled, crossover study is assessment of safety, tolerability and efficacy of ARX-02 relative to placebo in cancer patients experiencing episodic breakthrough pain.
“We are pleased to have initiated the dosing of our first patient in this proof-of-concept haunt,” states AcelRx Chief Executive Officer Thomas Schreck. “Developing a fastacting opioid with a shorter half-life than fentanyl for cancer patients who experience sudden breakthrough pain represents a historic step towards effectively treating pain while minimizing comprehensive opioid exposure.”
Pamela Palmer, MD, PHD, AcelRx Chief Medical Fuzz adds, “The pharmacokinetic benefit of ARX-02 is optimal for the purpose this unwavering residents. In contrast to fentanyl-based products, the highly consistent tempo to peak plasma concentration and plasma half-way of life of two to four hours produces a closer match of outstanding drug concentration with the breakthrough travail event and allows a high degree of safety if patients need to redose for a younger breakthrough pain event.”
Fro breakthrough cancer pain in the arse
Multitudinous patients with lasting cancer-reciprocal pain also experience episodes of stark pain that “breaks through” the regular aching medication. Typically the pain flare lasts almost 15 – 60 minutes, and patients may ordeal several episodes per day. Currently, uttered transmucosal fentanyl-based products are the on the contrary approved treatments for cancer breakthrough pain. These products procure prolonged plasma half-lives that extend beyond four hours for most dosage strengths.
Nearly ARX-02
AcelRx is developing ARX-02, a different sublingual sufentanil NanoTab offshoot candidate, as a new treatment option for patients with breakthrough cancer irritation. Sufentanil is a hard-wearing opioid that is almost 5-10 times more potent than fentanyl yet has an 80-go bust wider safety margin (therapeutic index), as ascertained in animal studies. The NanoTab is a very pocket-sized tablet designed to allow the rapid uptake of sufentanil following position included the tongue, maximizing transmucosal dope comprehension and limiting the expanse of swallowed drug. ARX-02 enables lightning-fast onset of discomfort elevation with a consistent, somewhat short duration of performance, more closely matching the timing of a breakthrough pain episode.
Hither AcelRx Pharmaceuticals, Inc.
AcelRx pharmaceuticals is a privately held pharmaceutical company dedicated to the development and commercialization of new therapies for the treatment of pain and other conditions where there is an unmet need over the extent of improved refuge and efficacy. The associates applies its proprietary dosage form and delivery technologies to enhance the safety, therapeutic good and commercial attractiveness of currently approved compounds.
Source: AcelRx Pharmaceuticals, Inc