Acura Says Results from Top-Line Study 'Not Statistically Significant'; Rigel Announces R343 Did Not Meet Endpoints in Asthma Trial Print E-mail
By Staff and Wire Reports   
Monday, 26 August 2013 23:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 26, 2013.

Acura Pharmaceuticals, Inc. (NASDAQ: ACUR)
announced top-line results from Study AP-ADF-301 (Study 301), a phase II clinical study in 40 recreational drug abusers assessing the abuse liability of snorting a crushed hydrocodone bitartrate with acetaminophen tablet formulated with Acura's abuse deterrent AVERSION technology (AVERSION H&A).

The results for AVERSION H&A in Study 301 were consistent in certain respects with the results of a similar study for another AVERSION product containing oxycodone hydrochloride, which has been approved by the US Food and Drug Administration (FDA). Study 301's primary endpoint indicated AVERSION H&A had slightly lower numeric mean maximum drug liking (Emax: 72.1) compared to an equivalent dose of a generic hydrocodone/acetaminophen tablet (Generic H&A: Emax: 75.6) currently on the market, however these results were not statistically significant (p > 0.025).

The secondary endpoints demonstrated the effects of the AVERSION ingredients on drug snorting. AVERSION H&A's mean minimum liking (Emin: 40.2) was less than Generic H&A (Emin: 50.4) (the difference being statistically significant at p=0.0003). The mean minimum drug liking for AVERSION H&A and the placebo control were 40.2 and 48.8, respectively (the difference being statistically significant at p=0.0042). A score below 50 indicates a subject disliked the drug they were taking at some point during the treatment (a score of 50 means neither like or dislike), and a score greater than 50 indicates they liked the drug they were taking.

The mean minimum liking results correlated closely the Overall Drug Liking score (ODL) and Take Drug Again assessment (TDA). ODL assessed the subject like or dislike for the drug experience 12 hours after taking the dose. The ODL for AVERSION H&A (52.7) was lower than Generic H&A (71.0) (the difference being statistically significant at p=0.0001) with a score of 50 indicating a neither a like or dislike. TDA assessed a subject's willingness to take the drug again assessed 12 hours after taking the dose. The TDA for AVERSION H&A (45.1) was lower than Generic H&A (71.0) (the difference being statistically significant at p=0.0001) with the AVERSION H&A score below 50 indicating an unwillingness to take the drug again.

There were no serious adverse events reported for AVERSION H&A. There was no sequence effect identified in the study but a carryover effect between the 5 study crossover periods was identified for the Emax measure but not the Emin measure. This effect is being further evaluated.

Acura intends to further evaluate the data from this study and plans to meet with the FDA to discuss these results. AVERSION H&A tablets contain a unique composition of inactive ingredients intended to deter common methods of prescription drug abuse such as snorting. Given the absence of statistical significance in Study 301s primary endpoint relating to maximum drug liking, the timeline for submission of a New Drug Application (NDA) for AVERSION H&A is expected to be delayed. The revised projected timeline for submission of the NDA for Aversion H&A will be determined following our meeting with the FDA. Although we do not expect the need to conduct additional nasal abuse like/dislike studies for AVERSION H&A, this will not be confirmed until our meeting with the FDA to discuss the Study 301 results.

Some of the significant differences observed in Study 301 compared to the results seen for the AVERSION oxycodone hydrochloride product study include, but are not limited to: (a) mean maximum drug liking scores for the active comparator (i.e. Generic H&A) were significantly lower, (b) the time to mean minimum drug liking for AVERSION H&A was longer, (c) almost all AVERSION H&A subjects snorted the entire dose compared to only 48% for AVERSION oxycodone hydrochloride, and (d) AVERSION oxycodone hydrochloride achieved a statistically significant reduction in mean maximum drug liking scores before adjusting for an observed sequence effect.

The Company will host a conference call to discuss the results on Tuesday, August 27 at 8:30 a.m. ET. To participate in the live conference call, please dial 888-539-3696 (U.S. and Canada) five to ten minutes prior to the start of the call. The participant passcode is 8585569.




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Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced that R343, an inhaled SYK inhibitor being evaluated as a potential therapeutic for patients with allergic asthma, did not meet the primary or secondary endpoints in a recently completed Phase 2 clinical study.

The primary endpoint was the change in pre-bronchodilator FEV1 (a measure of lung function) from baseline to dosing completion at Week 8, comparing active doses to placebo. R343 was shown to be relatively safe and well tolerated at both doses. In light of these overall findings, the company has decided not to pursue this indication with R343.




Also Monday:




The Alkaline Water Company Inc. (OTCBB: WTER), developers of an innovative, state of the art, proprietary electrolysis beverage process, packaged and sold as a bulk premier alkaline drinking water for balanced lifestyles, is pleased to announce its' bulk size, mineral enhanced Alkaline Water has received approval for inclusion as part of the United Natural Foods, Inc. (UNFI) national distribution network.

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, supports the U.S. Food and Drug Administration's (FDA's) proposed reclassification of rapid influenza detection tests.

China Cord Blood Corporation (NYSE: CO), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced its preliminary unaudited financial results for the first quarter of fiscal year 2014 ended June 30, 2013.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products, today announced its financial results for the half year ended June 30, 2013.

In a release issued under the same headline earlier today by EDAP TMS SA (Nasdaq:EDAP), please note that the presentation time should be 10:50 am ET – 11:15 am ET, rather than 10:25 am ET – 10:50 am ET as originally stated.

Fibrocell Science, Inc. (NYSE MKT:FCSC), an autologous cell therapy company focused on the development of innovative products for aesthetic, medical and scientific applications, announced today the appointment of Greg Weaver as Chief Financial Officer, Senior Vice President, Treasurer and Corporate Secretary of the Company.

HP (NYSE: HPQ) today announced that healthcare delivery systems provider Cerner Corporation is using the HP Vertica Analytics Platform as part of its high-end solutions for healthcare providers.

InspireMD, Inc. (NYSE MKT: NSPR)
, a leader in embolic protection stents, today announced it has completed the first phase of a manufacturing consolidation that the Company believes will improve its long term gross margins.

LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME) today announced its financial results for the second quarter ended June 30, 2013, reported in United States dollars and in accordance with International Financial Reporting Standards ("IFRS").

Life Technologies Corporation (NASDAQ: LIFE)
today announced the expansion of its food safety portfolio by partnering with PIKA Weihenstephan to provide molecular testing solutions for the detection of spoilage organisms in the brewing and beverage market.

MediSwipe Inc. (OTCQB: MWIP)
, the leader in Compassionate Care Technology Solutions for the medicinal marijuana industry and 800 Commerce Inc., an innovative online directory and mobile marketing company, today announced it has set a firm record date of September 3, 2013 for the previously announced distribution to its shareholders of MediSwipe Inc.

Merus Labs International Inc. (TSX:MSL) (NASDAQ:MSLI)
is pleased to announce the divestiture of the North American product rights for FACTIVE® (Gemifloxacin Mesylate) tablets to Okana Ventures Inc. (OTCBB:OKNV) for gross proceeds of approximately US$3.4 million.

MMRGlobal, Inc. (OTCQB: MMRF)
, a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that as a result of the Expedited Patent Allowance Program referred to as the Patent Prosecution Highway ("PPH"), and following the issuance of U.S. patents to MMR for its anti-CD20 monoclonal antibodies, the Company has received confirmation of the filings of a divisional application for its antibody technology in Japan, No. P09277JP01, as well as the filing on August 23, 2013 of a divisional Korean patent application, No. 10-2013-7022383.

MTS Systems Corporation (NASDAQ: MTSC), a leading global supplier of high-performance test systems and position sensors, today announced the 30-year anniversary of a collaboration with Tongji University in Shanghai to support disaster-reduction research in civil engineering.

NanoString Technologies, Inc. (Nasdaq:NSTG), today announced that it will be participating in two upcoming investor conferences. NanoString Technologies management is scheduled to participate in the 2013 Morgan Stanley Global Healthcare Conference in New York on Monday, September 9, 2013 at 11:45 am ET. NanoString Technologies management is also scheduled to present at the 2013 Baird Healthcare Conference in New York on Wednesday, September 11, 2013 at 10:15 am ET.

Former United States Securities and Exchange Commission attorney Willie Briscoe and the securities litigation firm of Powers Taylor, LLP are investigating the merger of Onyx Pharmaceuticals, Inc. (“Onyx”) (NasdaqGS: ONXX) with Amgen, Inc. for shareholders.

SK3 Group, Inc. (PINKSHEETS: SKTO) announces that its Investor relations consultant, Rubicon Capital Advisors has completed a dedicated web, phone and email presence for SKTO shareholder information.

Wound Management Technologies, Inc. (OTCQB: WNDM)
announces an increase in sales of CellerateRX® for the second quarter, ending June 2013 up 54% over the same period in 2012. Sales year to date have risen 111% over year to date sales in 2012.



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