Intravenous patient-controlled analgesia, or I.V. PCA, is the standard of care in many hospitals for the management of acute postoperative pain. The most commonly used opioid drug for I.V. PCA is Morphine, though other opioids like Oxycodone and Fentanyl are also used. Although widely used, I.V. PCA is said to have a number of drawbacks because of the side effects of Morphine, the invasive IV route of delivery and the inherent potential for programming and delivery errors associated with the complexity of infusion pumps.
Working to minimize some of the limitations, safety problems and side effects associated with the standard I.V. PCA is development stage company AcelRx Pharmaceuticals Inc. (ACRX: Quote), which has four product candidates in clinical development.
For readers who are new to AcelRx, here's a brief overview of the company and the upcoming events to watch out for...
The company's lead product candidate, ARX-01, which is designed to address I.V. PCA problems, is under phase III testing.
Unlike the standard I.V. PCA, which uses Morphine, ARX-01 utilizes Sufentanil, a high therapeutic index opioid, NanoTabs, a proprietary, non-invasive sublingual dosage form, and a novel hand-held PCA system.
The first phase III study evaluating ARX-01 in adults following open abdominal surgery was initiated in March of this year. The study, which is designed to enroll about 150 adults, will be conducted at 12 academic and community hospitals in the United States. The company expects to have the data from this study in the second half of this year.
A second phase III study comparing the efficacy and safety of ARX-01 to the standard of care I.V. PCA with Morphine, in the treatment of acute post-operative pain immediately after major abdominal or orthopedic surgery was initiated in April of this year. The study, which is designed to enroll about 400 adult patients will be conducted at 32 academic and community hospitals in the United States. Top-line data from this study is also expected in second half of this year.
A third phase III clinical study evaluating ARX-01 in treating post-operative pain following major joint replacement surgery is expected to start in the third quarter of 2012. Top-line data from this trial is expected by late 2012 or early 2013.
Also in the company's pipeline are:
* ARX-02 for the treatment of cancer breakthrough pain, which has completed phase II clinical development.
* ARX-03, designed to provide mild sedation, anxiety reduction and pain relief for patients undergoing painful procedures in a physician's office, which has also completed phase II clinical development.
* ARX-04 for management of moderate-to-severe acute pain, both on the battlefield and in civilian settings of trauma or injury, which is set to enter a phase II study. The product candidate was initially expected to enter phase II study in the second half of 2011.
According to a recent SEC filing, future development of ARX-02 and ARX-03 is contingent upon additional funding or establishing corporate partnerships. The development of ARX-04 is supported by the US Army Medical Research and Material Command, or USAMRMC. Last May, the company was awarded $5.6 million by the USAMRMC for the development of ARX-04.
A quick look at the company's balance sheet...
Since inception in July 2005 through March 31, 2012, AcelRx had an accumulated deficit of $95.7 million. The company has not generated any revenue from the sale of its products, and the revenue of $1.4 million generated till date is related to the grant award from the USAMRMC.
In the first quarter ended March 31, 2012, the company incurred a net loss of $7.1 million or $0.36 per share on revenue of $329 thousand. This compares with a net loss of $3.2 million or $0.30 per share on nil revenue in the year-ago first quarter.
AcelRx ended the first quarter of 2012 with cash of $27.6 million and debt of $19.18 million. (* Data sourced from Yahoo Finance)
The company went public in February 2011, pricing its shares at $5 each. The stock has thus far hit a 52-week low of $1.76 and a 52-week high of $5.00. ACRX closed Thursday's trading at $3.15, up 6.06%. The stock is thinly traded with an average 3-month volume of just 3,870 shares.
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by RTT Staff Writer
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