Previewing a Pair of Pain Drug FDA Decisions

Includes: ACUR, PFE, PTIE
by: Mike Havrilla

Acura Pharma (NASDAQ:ACUR) is a specialty pharmaceutical company focused on the development of abuse-deterrent products through its proprietary Aversion and Impede Technologies.

In late April, $ACUR reported its 1Q11 financial results and pipeline update, including …

  • As of 4/27/11, had 44.8 million (M) shares of common stock outstanding and $20.7M in cash equivalents with no debt.
  • Sufficient cash to fund operations for at least the next 12 months w/ 1Q11 net loss of ($2.9M).

Also in late April, $ACUR announced condolences to the family of its former President & CEO, Andrew Reddick, who passed away while on medical leave. In early May, $ACUR announced that the company's SVP & COO, Robert Jones, was appointed interim President and CEO. Below is a summary of the Company's pipeline, including a pending FDA decision expected in mid-June under a six-month priority review …

1.) FDA Decision (NDA) (Priority Review) -- ACUROX (immediate-release oxycodone, Aversion abuse-deterrent formulation without niacin)

On 2/10/11, the FDA notified partner King Pharma (acquired by Pfizer (NYSE:PFE)) that the New Drug Application was accepted with a six-month priority review and PDUFA action goal date of 6/17/11, seeking approval for the relief of moderate to severe pain and designed to deter potential abuse by IV injection of dissolved tablets or snorting crushed tablets. The FDA also issued preliminary comments to Pfizer in its filing communication letter regarding potential review issues surrounding the intranasal abuse liability study included w/ the submission in support of ACUROX approval.

$ACUR states the following in its most recent SEC 10-Q filing, "The FDA has publicly stated that abuse-deterrent label claims or indications require robust, long-term epidemiological data supporting a change in levels of abuse in the community over a reasonably long period of time. We believe the cost, time and practicality of designing and implementing clinical studies, as opposed to epidemiology studies, adequate to support explicit labeling claims of abuse deterrence are prohibitive.

The FDA has stated that scientifically derived data and information describing the physical characteristics of a product candidate and/or the results of laboratory and clinical studies simulating product abuse may be acceptable to include in the product label. We intend to include in the labels of our Aversion Technology product candidates (whether with or without niacin) both a physical description of the abuse deterrent characteristics and information from our laboratory and clinical studies designed to simulate the relative difficulty of abusing our product candidates."

Here is a link to the complete background and clinical trials for this product candidate …

2.) Impede PSE (pseudoephedrine 30mg) Tablets – same active ingredient as the widely-used over-the-counter (OTC) decongestant SUDAFED formulated w/ Impede Technology to deter the extraction of PSE from tablets, which may be abused as a starting material in meth labs for the illegal production of methamphetamine. $ACUR has scaled up its manufacturing process for the commercial distribution of Impede PSE and has demonstrated both bioequivalence to both brand / generic SUDAFED formulations and the ability to impede the extraction of PSE using the three most common methods.

$ACUR believes Impede PSE meets FDA requirements for OTC sale without the need for submitting a NDA and the Company expects to market the product directly to drug store chains in the US. Although products w/ 60mg or less of PSE are sold OTC in the US, federal legislation passed in 2006 requires PSE products be kept behind the pharmacy counter w/ purchases tracked and limited to counter use of PSE in meth labs while some states have enacted additional restrictions that require a prescription for PSE products.

Here is a link to the complete background and clinical trials for this product candidate …

3.) ACUROX with Niacin Tablets – NDA was originally submitted in late DEC 2008 w/ a Complete Response Letter (NYSE:CRL) issued by FDA on 6/30/09. The FDA subsequently held an advisory panel meeting on 4/22/10, which voted 19-1 against approval due to inclusion of niacin in the product; arguing there was not sufficient evidence to support approval and questioned increased incidence of flushing associated w/ niacin, lack of evidence supporting abuse-deterrent ability of niacin when drug taken at high / abused doses, and potential to counter the side effects such as niacin flushing via ingesting food or commonly available OTC drugs such as aspirin.

$ACUR and $PFE have conducted an additional oral abuse liability trial (Study 114) that was not included in the original NDA filing for ACUROX with Niacin Tablets. The companies continue to evaluate the results of this study and expect to submit a response to the JUN 2009 CRL once these analyses are completed.

Here is a link to the complete background and clinical trials for this product candidate, including a link to Study 114 …

As evidenced by the wording of $ACUR's most recent SEC 10-Q filing and the FDA filing communication letter, there is a degree of uncertainty surrounding the degree of clinical / lab testing required to support abuse-deterrent claims. In addition, the prospects for a successful reply to FDA to address the CRL for ACUROX with Niacin Tablets is uncertain given the nearly unanimous vote against approval due to the inclusion of niacin and whether Study 114 can resolve these concerns. However, despite these uncertainties, $ACUR is poised for a likely run-up ($5-6 price target) going into the expected mid-June FDA decision.

Below is a summary of another pending abuse-detterent pain drug FDA decision for Pain Therapeutics (NASDAQ:PTIE):

FDA Decision (Class 2 Resubmission) -- REMOXY (controlled-release, abuse-deterrent oxycodone twice-daily oral pain drug)

In JAN 2011, FDA accepted as Class 2 resubmission w/ PDUFA decision goal date of 6/23/11, licensed to King Pharma (acquired by $PFE) w/ $PTIE due to receive $15M upon FDA approval, 20% royalties (10% ex-US), based on $DRRX drug delivery which is due to receive 6-11.5% royalties … on 4/25/11, REMOXY met primary endpoints in an abuse liability study vs. the standard formulation of oxycodone extended-release (ER) tablets.

On 5/3/11, $PFE 1Q11 conference call approx. 9:10-9:45 section of the audio replay addresses pending FDA decision for REMOXY …

… working to address specific issue in the manufacturing section plus assessing the potential implications for class-wide REMS (Risk Evaluation and Mitigation Strategy) requirement by FDA for extended-release ER opioid products, which could result in potential delay to approval / launch timelines for REMOXY.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.