Last $0.58 USD
Change Today -0.0061 / -1.03%
Volume 43.2K
ACUR On Other Exchanges
Symbol
Exchange
Berlin
NASDAQ CM
As of 8:10 PM 10/22/14 All times are local (Market data is delayed by at least 15 minutes).

acura pharmaceuticals inc (ACUR) Snapshot

Open
$0.59
Previous Close
$0.59
Day High
$0.60
Day Low
$0.58
52 Week High
02/27/14 - $2.12
52 Week Low
10/20/14 - $0.57
Market Cap
28.5M
Average Volume 10 Days
63.7K
EPS TTM
$-0.29
Shares Outstanding
48.8M
EX-Date
--
P/E TM
--
Dividend
--
Dividend Yield
--
Current Stock Chart for ACURA PHARMACEUTICALS INC (ACUR)

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acura pharmaceuticals inc (ACUR) Details

Acura Pharmaceuticals, Inc., a specialty pharmaceutical company, researches, develops, and commercializes products to address medication abuse and misuse utilizing its proprietary Aversion and Impede technologies. The company’s products include Oxecta tablets, a Schedule II narcotic indicated for the management of acute and chronic moderate to severe pain; and Nexafed, a pseudoephedrine HCl tablet that is used as a nasal decongestant in various non-prescription and prescription cold, sinus, and allergy products. It has seven additional opioid products, including hydrocodone bitartrate/acetaminophen, methadone HCl, morphine sulfate, oxycodone HCl/acetaminophen, oxymorphone HCl, and tramadol HCl tablets utilizing Aversion technology in various stages of development. The company has a license, development, and commercialization agreement with King Pharmaceuticals Research and Development, Inc. to manufacture and commercialize Oxecta products in the United States, Canada, and Mexico. Acura Pharmaceuticals, Inc. was founded in 1935 and is based in Palatine, Illinois.

15 Employees
Last Reported Date: 03/3/14
Founded in 1935

acura pharmaceuticals inc (ACUR) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $383.0K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $219.0K
Vice President of Technical Affairs
Total Annual Compensation: $282.0K
Vice President, Treasurer and Corporate Contr...
Total Annual Compensation: $170.0K
Vice President of Corporate Development
Total Annual Compensation: $170.0K
Compensation as of Fiscal Year 2013.

acura pharmaceuticals inc (ACUR) Key Developments

Acura Pharmaceuticals Inc. Provides Update on its Hydrocodone Bitartrate with Acetaminophen Tablets Development

Acura Pharmaceuticals Inc. announced that the US Food and Drug Administration (FDA) has denied on procedural grounds Acura's appeal of the position taken by Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) that abuse by snorting of hydrocodone with acetaminophen products lacks relevance. Relevance is defined in FDA's January 2013 Draft Guidance on the evaluation and labeling of abuse deterrent opioids to be a "known or expected" route of abuse for that product. In a letter decision from the Office of Drug Evaluation II, the FDA indicated that DAAAP's comments and correspondence to date with Acura, as well as the Draft Guidance on abuse deterrent opioids, should be viewed only as recommendations and opinions and do not preclude Acura from completing its clinical development and submitting a New Drug Application for its hydrocodone with acetaminophen product for consideration. FDA further noted that for issues such as abuse-deterrence an Advisory Committee meeting may greatly inform their considerations. The FDA's letter also advised the Company that may appeal this decision to the next level within the FDA. Acura is assessing its development strategy for its abuse deterrent hydrocodone with acetaminophen program, including the merits of appealing the FDA's decision.

Acura Pharmaceuticals Inc. Announces Preliminary Results from Three Clinical Studies for its Abuse Deterrent

Acura Pharmaceuticals Inc. announced preliminary results from three clinical studies for its abuse deterrent AVERSION(R) hydrocodone bitartrate with acetaminophen (AVERSION H/A) development product with the key study demonstrating that AVERSION H/A met the objective of conformance with the Food and Drug Administration's (FDA) standards for bioequivalence when compared to the reference drug NORCO(R), when taken in the fasted state. A food effect was observed with the AVERSION H/A formulation with lower peak blood concentrations for both hydrocodone and acetaminophen than the comparator product. Further, the studies demonstrated dose proportionality, or relatively consistent blood exposure, across all three dosage strengths of AVERSION H/A. Finally, Acura evaluated blood levels of hydrocodone compared to VICOPROFEN(R) and of acetaminophen compared to ULTRACET(R), for additional safety. AVERSION H/A blood levels of hydrocodone were consistent with the comparator product while acetaminophen peak blood levels were higher than those observed for the comparator product. AVERSION H/A was generally well tolerated in all the clinical studies with no serious adverse events observed. AVERSION H/A exhibited consistent exposure levels of hydrocodone and acetaminophen across all three studies. Acura continues to review the results from these studies. The three Acura studies, Study AP-ADF-302, AP-ADF-303 and AP-ADF-304, conclude Acura's planned clinical studies to demonstrate the pain relief efficacy and safety of AVERSION H/A. Acura believes the level of food effect observed and the increased peak exposure to acetaminophen are not clinically relevant, but all these results will be subject to FDA review and concurrence. Acura has previously indicated the need to provide additional clinical data on the snorting abuse deterrent features of AVERSION H/A which is pending the successful completion of a dispute resolution proceeding Acura initiated with the FDA regarding FDA's determination that snorting is not a relevant route of abuse for hydrocodone combination products. Study AP-ADF-302 is an open label, single dose, randomized, crossover study in 36 healthy adult subjects measuring blood concentration of hydrocodone and acetaminophen in fed and fasted states. In the fasted state, a single AVERSION H/A 10/325mg tablet was found to meet FDA's standards for bioequivalence compared to an equivalent dose of NORCO. A finding of bioequivalence compared to an FDA approved drug is typically sufficient to establish the safety and efficacy of a test formulation. AVERSION H/A 10/325mg was also tested in the fed state following a standardized meal, which demonstrated a 13.7% and 34.4% average reduction in peak blood concentration for hydrocodone and acetaminophen, respectively, compared to NORCO in the fasted state. These food effect results are consistent with the AVERSION technology and also the known effect of food on acetaminophen in general and the reduction is not expected to have a meaningful clinical impact. Study AP-ADF-303 is an open label, single dose, randomized, crossover study in 24 healthy adult subjects measuring blood concentration of hydrocodone and acetaminophen in the fasted state across three different dose levels of AVERSION H/A. The blood exposure of hydrocodone and acetaminophen were proportionately the same across all three doses of AVERSION H/A successfully demonstrating dose consistency of the formulation. Study AP-ADF-304 is an open label, single dose, randomized, crossover study in 24 healthy adult subjects measuring blood concentration of hydrocodone and acetaminophen in the fasted state to determine pharmacokinetics and safety of AVERSION H/A 7.5/325mg compared to equivalent doses of VICOPROFEN (for hydrocodone) and ULTRACET (for acetaminophen), for additional safety. Extent of exposure, measured by Area Under the Curve or AUC, is comparable for both hydrocodone and acetaminophen between AVERSION H/A and the respective comparator products. The peak exposure, measured by maximum plasma concentration or Cmax, is consistent for hydrocodone but AVERSION H/A was approximately 23% higher than the comparator based on the geometric mean. A large variability in acetaminophen results is observed in the study and is being further evaluated.

Acura Pharmaceuticals Receives Non-Compliance Notice From NASDAQ

On September 18, 2014, Acura Pharmaceuticals, Inc. received a letter from the Listing Qualifications Staff (Staff) of The NASDAQ Stock Market notifying Acura that because the closing bid price of its common stock has been below $1.00 for 30 consecutive business days, it no longer complies with the requirements for continued listing on The NASDAQ Capital Market set forth in NASDAQ Listing Rule 5550(a)(2). The NASDAQ notice does not impact Acura’s listing on The NASDAQ Capital Market at this time. In accordance with NASDAQ Listing Rule 5810(c)(3)(A), the Company has been provided a period of 180 calendar days, or until March 17, 2015, in which to regain compliance. In order to regain compliance with the minimum bid price requirement, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of ten consecutive business days during this 180 day period. If Acura does not demonstrate compliance with Listing Rule 5550(a)(2) by March 17, 2015, the Staff will determine whether Acura meets the applicable market value of publicly held shares requirement for continued listing and all other applicable standards for initial listing on the NASDAQ Capital Market (except the bid price requirement). If Acura meets such criteria, it may be eligible for an additional 180 day compliance period. If Acura does not regain compliance, its common stock will be subject to delisting. At that time, Acura may appeal to a NASDAQ Listing Qualifications Panel (Panel), and Acura’s common stock would remain listed pending the Panel’s decision following a hearing. The Company intends to monitor the bid price of its common shares between now and March 17, 2015, and will consider available options to regain compliance with the listing requirements. There can be no assurance that the Company will be able to regain compliance with the minimum bid price requirement or maintain compliance with the other listing requirements.

 

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