Profile: AcelRx Pharmaceuticals Inc (ACRX.O)

ACRX.O on Consolidated Issue listed on NASDAQ Global Market

24 Nov 2014
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AcelRx Pharmaceuticals, Inc., incorporated on July 13, 2005, is a development-stage company. It is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of acute and breakthrough pain. The Company has completed Phase 2 clinical development for two additional product candidates, the Sufentanil NanoTab BTP Management System, or ARX-02, for the treatment of cancer breakthrough pain (BTP), and the Sufentanil/Triazolam NanoTab, or ARX-03, designed to provide mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician’s office. The Company is preparing to initiate two Phase 3 clinical trials for its product candidate, the Sufentanil NanoTab PCA System, or ARX-01. Its operations are based in Redwood City, California.

ARX-01 Description

ARX-01 allows patients to self-administer sublingual sufentanil NanoTabs as needed to manage their post-operative pain in the hospital setting, and provides the record-keeping attributes of a intravenous patient-controlled analgesia (IV PCA) pump while avoiding some of the issues, such as programming errors associated with conventional IV PCA use. The Company’s Sufentanil NanoTab PCA System, ARX-01, consists of three components: sufentanil, a high therapeutic index opioid; NanoTabs, its non-invasive sublingual dosage form, and its handheld patient-controlled analgesia (PCA) device that enables simple patient-controlled delivery of NanoTabs in the hospital setting and eliminates the risk of programming errors. ARX-01 utilizes sufentanil, which has therapeutic indices of all commercially available opioids, making it a candidate for the management of post-operative pain. Formulated in its sublingual NanoTab dosage form, sufentanil provides for relatively high bioavailability, with lower peak drug levels and a longer duration of action compared to IV delivery.

The Company’s handheld PCA device consists of a stack of 40 sufentanil 15 microgram NanoTabs (approximately a two-day supply) in a disposable radio frequency identification and bar-coded cartridge; a disposable dispenser tip, and a reusable, rechargeable handheld controller. It has completed three Phase 2 clinical trials of sufentanil NanoTabs in the post-operative setting. In the first Phase 2 study, it conducted a randomized, double-blind, placebo-controlled, multicenter Phase 2 clinical study. The Company also conducted an open-label functionality and study of the ARX-01 NanoTab delivery system in patients undergoing elective unilateral knee replacement surgery. Its second Phase 2 study tested sufentanil NanoTabs 10 microgram, 15 microgram, or placebo in patients undergoing abdominal surgery. The Company has conducted an open-label functionality study of the ARX-01 NanoTab delivery system in patients undergoing elective unilateral knee replacement surgery.

ARX-02 Description

ARX-02 is a product candidate for the treatment of cancer patients who suffer from breakthrough pain. ARX-02 consists of a magazine containing 30 single dose applicators (SDAs) loaded into a multiple SDA dispenser (MSD). Each single dose applicator includes a sufentanil NanoTab that a patient can self-administer to their sublingual space for oral transmucosal absorption. The MSD dispenses SDAs; displays a recent dose indicator that is designed to mitigate overdosing; has child resistant, and provides electronic date and time stamping of each SDA removal event. The Company focuses to conduct one Phase 3 efficacy study for ARX-02 for the management of cancer breakthrough pain in adult patients, who are already taking opioids for their underlying persistent cancer pain. In addition, it focuses to conduct two open-label studies to demonstrate the use of the MSD. It has completed a Phase 2 study of the analgesic efficacy of the sufentanil NanoTab in adult cancer patients who are opioid tolerant and suffering from breakthrough pain events.

ARX-03 Description

ARX-03 Sufentanil/Triazolam NanoTab is a single, fixed-dose sublingual product candidate designed to be administered by a healthcare professional prior to a painful procedure in a physician’s office. Its Phase 2 clinical data showed that administering ARX-03 through sublingual route prior to a procedure results in a rapid onset of mild sedation and reduction in anxiety in 15 to 30 minutes. Sufentanil and triazolam have short half-lives enabling patients treated with ARX-03 to be discharged immediately following completion of the procedure. The Company has completed a Phase 2 clinical trial of ARX-03 demonstrating rapid onset of mild sedation and anxiety reduction, with a low adverse event profile during an abdominal liposuction procedure. Two four-arm factorial Phase 3 studies will be required with a minimum of 700 patients exposed to active drug. It focuses to conduct two Phase 3 efficacy studies in a range of painful procedures, such as prostate biopsy, breast biopsy, vasectomy and low-volume abdominal liposuction. It has completed an initial dose finding study for the sublingual Sufentanil/Triazolam NanoTabs (10 microgram/100 microgram, 10 microgram/200 microgram and 15 microgram/200 microgram) in 24 subjects. The Company completed a Phase 2 study of analgesic and anxiety reducing efficacy of the sufentanil/triazolam NanoTab in patients undergoing an elective abdominal liposuction procedure.

The Company competes with Cephalon, Inc., Meda Pharmaceuticals Inc. / BioDelivery Sciences International, Inc., ProStrakan Group plc, Nycomed International Management GmbH, Archimedes Pharma Limited, Teva Pharmaceuticals USA, Akela Pharma, Inc., Insys Therapeutics, Inc., Hospira Inc., CareFusion Corporation, Baxter International Inc., Curlin Medical, Inc., Smiths Medical, Avancen MOD Corporation, Johnson & Johnson, Incline Therapeutics, Inc. and Javelin Pharmaceuticals, Inc.

Company Address

AcelRx Pharmaceuticals Inc

351 Galveston Drive
P: +1650.2163500
F: +1650.2166500

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