FDA allows generic forms of Endo Health's Opana ER painkiller

(Reuters) - The U.S. Food and Drug Administration on Friday denied Endo Health Solutions' petition to block generic forms of its widely abused prescription pain drug Opana ER, a surprise decision by an agency that has recently come down hard on pain drugs to prevent their abuse.

Prescription drug abuse leads to more deaths in the United States than heroin and cocaine combined, according to the U.S. Centers for Disease Control and Prevention.

The company had argued that its reformulated version of Opana ER, a powerful opioid painkiller containing oxymorphone, would be more difficult to abuse than the original version, and therefore asked that generics of the earlier version be barred from the market.

However, the FDA determined that the original formulation of the drug had not been withdrawn from the market for reasons of safety or effectiveness and so its generic forms could continue to be approved and marketed. (r.reuters.com/huj97t)

The regulator also noted that reformulated Opana ER could still be manipulated for abuse in certain ways and that one of the new version's post-marketing investigations had raised the possibility that it may be more susceptible to abuse via injection than the original.

The agency's decision comes a month after it said it would not approve any generic versions of the original form of the pain medication OxyContin, which was widely abused because it could be crushed and then snorted or injected to produce a quick high.

That decision had led many analysts to expect that the FDA would side with Endo against the generics.

This expectation was also due to the formulations of Opana ER and OxyContin being very similar, said RBC Capital Markets analyst Shibani Malhotra.

"Implicitly, what the agency has done by not blocking Opana ER generics is (to say) that there is no benefit to using Opana ER when there are generics available," Malhotra said.

Endo said in a statement that it would explore all options to mitigate the effect of the FDA decision.

Opana ER brought in sales of about $299.3 million to Endo in 2012, down 22 percent from the earlier year because of the introduction of cheaper, copycats of the drug.

Following Friday's FDA decision, Endo said it estimates its 2013 net sales from Opana ER would fall by about $120 million, reducing operating profit by about 55 cents per share.

Michael Tong of Wells Fargo said the decision was a positive for Impax Laboratories Inc, whichmarkets all strengths of generic Opana ER.

Endo shares closed down 5 percent at $34.97 on the Nasdaq on Friday. Impax shares closed up 8 percent at $17.40.

Trading in Endo shares were suspended for about 5 minutes at 1521 ET, as the stock started falling after the FDA posted its decision on its website.

Nasdaq said the trading pause was erroneous and that it is "investigating the root cause of the issue and will take steps to prevent a future reoccurrence."

The stock was halted again at 1539 ET ahead of Endo's press release.

(Reporting by Zeba Siddiqui in Bangalore, additional reporting by Pallavi Ail; Editing by Anthony Kurian)

source:http://www.reuters.com

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Obama launches campaign to boost landmark healthcare program

(Reuters) - President Barack Obama launched a campaign to promote his signature 2010 healthcare overhaul on Friday in the face of harsh criticism from congressional Republicans who say the program will raise costs and hurt hiring.

"If you're one of the tens of millions who don't have health insurance, beginning this fall you'll finally be able to compare and buy quality, affordable private plans that work for you," he said at an event at the White House.

"If you've already got health insurance, this is just enhancement. And if you don't, you're going to be able to get it," he said.

Ahead of the Mothers' Day holiday on Sunday, the president focused his remarks on how the plan could benefit women, who the administration believes will be less stuck on partisan objections to the plan and provide support that will make what has become known as "Obamacare" a success.

"Mothers are the number one validator for the young and uninsured and will be critical in the effort to encourage their kids to enroll for insurance in the fall," a White House official said.

Republicans say the law will raise the costs of healthcare for all Americans, spawn a welter of new regulatory burdens on businesses and inhibit hiring.

"There are many women in their 20s and 30s who will be unable to afford the law's massive premium increases," Senate Minority Leader Mitch McConnell said on Thursday. "And there are many mothers who won't be able to get by if their employers cut their hours due to Obamacare. Or if they lose their jobs because of it," the Kentucky Republican said.

Obama aides plan to use the same micro-targeting strategies that helped the president win re-election in November to sign up enough enrollees. Their outreach efforts will be central to the success of Obama's Patient Protection and Affordable Care Act, which aims to bring health insurance at subsidized rates to millions of uninsured Americans.

Administration officials hope to sign up 7 million people nationwide during an enrollment period that begins October 1 and runs through the end of March. They say they are zeroing in on an estimated 2.7 million healthy adults aged 18 to 25.

One-third of these people live in three states: California, Florida, and Texas, officials said. The administration plans to go into communities to identify people who are eligible to try to persuade them to enroll in the insurance plan.

The White House on Thursday announced a $150 million initiative to fund the hiring and training of thousands of workers who will go through community health centers to help people obtain insurance.

But political resistance to the plan is high, and public opinion polls still show disapproval outweighing approval of the healthcare law.

The fate the of healthcare plan is expected to have a major bearing on the 2014 midterm congressional elections. If Americans embrace Obamacare, Democrats could benefit, while rejection could provide an electoral boost to Republicans.

The Republican-controlled House of Representatives has voted to repeal or cut funding for the law three dozen times and intends to vote again next week to repeal the law. The measure is unlikely to be go anywhere in the Democrat-controlled Senate.

White House aides say they believe that once people start to receive benefits from expanded healthcare coverage, support for the law will grow and it will become harder for its opponents to argue for its repeal.

source:http://www.reuters.com

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