Key Developments: AcelRx Pharmaceuticals Inc (ACRX.W)
6.37USD
21 May 2013
$-0.10 (-1.55%)
$6.47
$7.06
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$6.37
2,000
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$7.35
$2.90
Latest Key Developments (Source: Significant Developments)
AcelRx Pharmaceuticals Inc Announces Top-Line Data Demonstrate Primary Endpoint Achieved In Final Pivotal Phase 3 Study Of Sufentanil Nanotab PCA System For Management Of Post-Operative Pain
AcelRx Pharmaceuticals Inc announced top-line data demonstrating that in a placebo-controlled Phase 3 study of its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System (NanoTab System), the primary efficacy endpoint was achieved. The study evaluated control of pain intensity compared to baseline during the 48-hour study period immediately following major orthopedic surgery, specifically knee or hip replacement, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (i.e. SPID-48). Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (+76.1 vs -11.5, p <0.001). Secondary endpoint data showed that SPID at 24 hours and 72 hours was also significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p <0.001 in each case). Adverse events reported in the study were generally mild or moderate in nature and were similar in both placebo and treatment groups for the majority of adverse events. Utilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 study enrolled 426 adult patients at 34 U.S. sites for treatment of moderate=to-severe acute pain immediately following major orthopedic surgery. Seven patients did not receive study drug, resulting in 419 patients being included in the intent-to-treat (ITT) population. Full Article
AcelRx Pharmaceuticals Inc Announces That Top-line Data Show Primary Endpoint Achieved in Pivotal Phase 3 Study of Sufentanil NanoTab PCA System For Post-Operative Pain
AcelRx Pharmaceuticals Inc announced top-line data results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups. The primary endpoint evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery. Results demonstrated that patients receiving sufentanil NanoTabs realized a significantly greater SPID-48 during the study period than placebo-treated patients (p=0.001). Secondary endpoint data also showed that 24 hours and 72 hours after first dose, SPID was significantly greater in the sufentanil-treated patients than in the placebo-treated patients (p<0.001 and p=0.004 respectively). Utilizing a randomized, double-blind, placebo-controlled design, this pivotal Phase 3 study enrolled 178 adult patients at 13 U.S. sites for the treatment of acute post-operative pain immediately following major abdominal surgery. Patients were treated for post-operative pain for a minimum of 48 hours, and up to 72 hours. Full Article
AcelRx Pharmaceuticals Inc Announces Appointment Of Chairman-Form 8-K
AcelRx Pharmaceuticals Inc reported in its Form 8-K that on February 11, 2013, Thomas Schreck submitted his resignation from the Board of Directors of AcelRx Pharmaceuticals, Inc. (Company), effective immediately. Effective immediately upon Mr. Schreck’s resignation from the Board, the Board elected Adrian Adams to the Board, to serve in the class of directors whose term of office expires at the Company’s 2015 Annual Meeting of Stockholders and until his successor is duly elected and qualified, or until his earlier death, resignation or removal. Mr. Adams was also named as the Chairman of the Board, effective immediately upon his election to the Board. Full Article
AcelRx Pharmaceuticals Inc Announces Exercise of Option to Purchase Additional Shares
AcelRx Pharmaceuticals Inc announced that the underwriters of its public offering have exercised, in full, their option to purchase an additional 1,875,000 shares of common stock at a public offering price of $3.31 per share. This option to purchase additional shares was granted to the underwriters in connection with AcelRx's previously announced underwritten public offering of 12,500,000 shares of its common stock, which was closed on December 12, 2012. The sale of option shares was closed on December 14, 2012. With the exercise of this option, the total gross proceeds of the public offering increased to approximately $47.6 million with estimated net proceeds to AcelRx of $44.2 million after deducting underwriting discounts and estimated expenses. Jefferies & Company, Inc. and Cowen and Company, LLC acted as joint book-running managers for the offering, with Canaccord Genuity Inc. acting as co-lead manager. Full Article
AcelRx Pharmaceuticals Inc Presents Top-Line Data From Phase 3 Study Of Sufentanil NanoTab PCA System vs. IV PCA Morphine
AcelRx Pharmaceuticals Inc announced top-line data from previously announced open-label, active-comparator study of lead product candidate, the Sufentanil NanoTab PCA System. Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p <0.001) to intravenous (IV) patient-controlled analgesia (PCA) with morphine for primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of good or excellent (78.5% vs. 66.1% respectively). The assessment of non-inferiority is based on a lower limit of -15% for the 95% confidence interval (CI) around the difference between these percentages. Because the 95% CI was +3.2% to +21.6% for the 48-hour PGA, a statistical analysis for superiority could be performed, which demonstrated that for this study, the NanoTab System was statistically superior to IV PCA morphine for the PGA endpoint (p=0.009). This statistically superior PGA was also seen at the 24 hour and 72 hour time points. Additionally, the percentage of patients rating the NanoTab System as Excellent was higher than those rating IV PCA morphine as excellent (42.9% vs. 30.6%, p=0.016). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due to an adverse event (7.9% vs. 11.1% respectively). Full Article
AcelRx Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
AcelRx Pharmaceuticals Inc announced the pricing of its previously announced underwritten public offering of 12,500,000 shares of its common stock, offered at a price of $3.31 per share to the public. The gross proceeds to AcelRx from this offering are expected to be approximately $41.38 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by AcelRx. All of the shares in the offering are to be sold by AcelRx. The offering is expected to close on or about December 12, 2012, subject to the satisfaction of customary closing conditions. AcelRx has granted the underwriters a 30-day option to purchase up to an aggregate of 1,875,000 additional shares of common stock. Jefferies & Company, Inc. and Cowen and Company, LLC are acting as joint book-running managers for the proposed offering, with Canaccord Genuity Inc. acting as co-lead manager. Full Article
AcelRx Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
AcelRx Pharmaceuticals Inc announced a proposed underwritten public offering of 10,000,000 shares of its common stock pursuant to a registration statement filed with the Securities and Exchange Commission (SEC). AcelRx will grant the underwriters a 30-day option to acquire up an additional 1,500,000 shares to cover over-allotments, if any. All of the shares in the offering are to be sold by AcelRx. Jefferies & Company, Inc. and Cowen and Company, LLC are acting as joint book-running managers for the proposed offering, with Canaccord Genuity Inc. acting as co-lead manager. Full Article
AcelRx Pharmaceuticals Inc Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System
AcelRx Pharmaceuticals Inc announced it had met the primary endpoint in the Phase 3 non-inferiority study of the sublingual Sufentanil NanoTab PCA System vs. IV PCA with morphine. The top-line data is expected to be released prior to market opening on November 15, 2012. Full Article
AcelRx Pharmaceuticals Inc Receives Fourth and Fifth U.S. Patents For Small-Volume Oral Transmucosal Dosage Forms
AcelRx Pharmaceuticals Inc announced that the U.S. Patent and Trademark Office (USPTO) has recently issued AcelRx Patent Number 8,252,328 entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery," and Patent Number 8,252,329 also entitled "Bioadhesive Drug Formulations for Oral Transmucosal Delivery." The '328 and '329 patents each make claims to a bioadhesive tablet for oral transmucosal administration of sufentanil. These newly issued patents will provide intellectual property protection for sufentanil NanoTab based products until at least January 5, 2027. Full Article
AcelRx Pharmaceuticals Inc Receives Two Additional U.S. Patents For Small-Volume Oral Transmucosal Dosage Forms
AcelRx Pharmaceuticals Inc announced that the U.S. Patent and Trademark Office (USPTO) has recently issued AcelRx Patent Number 8,226,978 entitled "Small Volume Oral Transmucosal Dosage Forms Containing Sufentanil for Treatment of Pain, and Patent Number 8,231,900 entitled Small-Volume Oral Transmucosal Dosage Forms. The '978 patent claims a dosage form for oral transmucosal administration of sufentanil and the '900 patent claims a small-volume solid tablet containing a single dose of sufentanil for oral mucosal administration to a subject. Full Article
AcelRX post-op pain treatment meets late-stage study goal
- AcelRX Pharmaceuticals Inc said its experimental treatment for post-operative pain met its main goal in a late-stage trial of patients who had undergone knee or hip replacement surgery, sending its shares up 15 percent.
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