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Purdue Pharma presents efficacy, abuse deterrent potential of pain medication Hysingla ER

BY Michael Johnsen

LAS VEGAS — At the PainWeek national conference on Thursday, Purdue Pharma shared results from several studies and post-hoc analyses evaluating its investigational pain medication, once-daily hydrocodone bitartrate, which is expected to be marketed under the trade name, Hysingla ER.
 
The investigational analgesic is a single-entity product that does not include acetaminophen. The tablets are formulated with abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting and intravenous injection).
 
The studies found that Hysingla ER was an effective pain reliever for patients with chronic pain and that the drug has a lower abuse profile as compared to other abuse-prone analgesics. 
 
“These studies continue to support the fact that, if approved by the Food and Drug Administration, Hysingla ER could be an important alternative for healthcare professionals treating patients in chronic pain with a hydrocodone product formulated with physicochemical properties intended to deter abuse,” stated Todd Baumgartner, VP research and development and chief medical officer at Purdue Pharma.
 
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Purdue Pharma: Abuse rates of OxyContin significantly down three years after reformulation

BY Michael Johnsen

STAMFORD, Conn. — Purdue Pharma on Thursday presented results from two epidemiological studies evaluating the reformulation of OxyContin, which occurred in 2010, that showed a marked decrease in rates of abuse, addiction and poisoning in the first year after the product was introduced to the marketplace with physicochemcial properties intended to decrease abuse, misuse and diversion by various routes of administration (e.g., snorting and intravenous injection). 
 
These studies also show that declines in abuse and diversion have persisted three years since the introduction. 
 
For the first study, among all patients prescribed OxyContin, diagnoses for opioid abuse, addiction or poisoning decreased by 12% when comparing the year before to the year after reformulation. The second study examined the abuse and diversion of reformulated OxyContin three years after being introduced on the market and found that in all surveillance systems, reductions in rates of abuse were observed for both oral and non-oral routes of administration although the magnitude of decline was larger for abuse through non-oral routes. Rates declined approximately 20% in the first quarter in the post-reformulation period (Q1 2011), to more than a 70% decline by the end of the 3-year follow-up (Q4 2013).
 
Purdue Pharma’s OxyContin is an extended-release oxycodone product that was originally approved by the Food and Drug Administration in 1995 and reformulated with abuse deterrent properties to make the tablet more difficult to manipulate for misuse and abuse. Approved in April 2010 the product was shipped in August 2010 when shipments of the original formulation ceased. OxyContin has physicochemical properties expected to make abuse via injection and intranasal route difficult. However, abuse of OxyContin by these routes, as well as by the oral route is still possible.
 
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Family Dollar response: Dollar General merger proposal won’t pass muster with FTC

BY Michael Johnsen

 

MATTHEWS, N.C. — Family Dollar on Friday rejected the revised proposal made by Dollar General on Sept. 2 on the basis of antitrust regulatory considerations. The Dollar General offer may be financially superior, the dollar store operator noted, but it's not likely to pass muster with the Federal Trade Commission. 
 
“Our board of directors, with the assistance of outside advisors and consultants, reviewed all aspects of Dollar General’s revised proposal and unanimously concluded that it is not reasonably likely to be completed on the terms proposed," stated Howard Levine, chairman and CEO of Family Dollar. "There is a very real and material risk that the transaction proposed by Dollar General would fail to close, after a lengthy and disruptive review process. Accordingly, our board has rejected Dollar General’s revised proposal and reaffirmed its support of the transaction with Dollar Tree, which delivers attractive value in the form of immediate upfront cash and upside participation in a combined Dollar Tree-Family Dollar entity, as well as closing certainty.”
 
“We are focused on delivering to Family Dollar shareholders the highest value with certainty, and the Dollar Tree transaction does just that. Dollar Tree has taken the antitrust risk off the table by committing to divest as many stores as necessary to obtain antitrust clearance. We remain fully committed to the Dollar Tree transaction,” added Ed Garen, a Family Dollar director and co-founder and chief investment officer at Trian Fund Management. “Dollar General’s revised proposal, on the other hand, does not eliminate regulatory risk for Family Dollar shareholders. Dollar General has repeatedly stated that antitrust is not a risk, yet they have put forth proposals that require Family Dollar shareholders to bear the ultimate risk. Receiving a reverse breakup fee with an after-tax value of less than $3 a share does virtually nothing to compensate the Family Dollar shareholders for assuming that risk.”
 
Family Dollar’s merger agreement with Dollar Tree contains a customary provision that permits Family Dollar to enter into discussions and share information with any competing bidder, but only if the board is able to determine that failure to do so would be inconsistent with its fiduciary duties and that the unsolicited, written proposal from the competing bidder would be reasonably expected to lead to a proposal that is not only financially superior, but also “reasonably likely to be completed on the terms proposed.”
 
Family Dollar contends that the FTC would take a more critical review of any proposed Dollar General/Family Dollar merger. 
 
The Family Dollar Board’s unanimous determination to reject Dollar General’s revised proposal and to accept Dollar Tree’s commitment to divest as many stores as required for antitrust approval follows the unanimous recommendation of a committee of four non-management independent directors that has been overseeing the company’s consideration and exploration of strategic alternatives since January 2014. This committee consists of Glenn Eisenberg, Ed Garden, George Mahoney, Jr. and Harvey Morgan.
 

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