Bloomberg News, 11/15/08 (http://www.bloomberg.com/apps/news?pid=20601202&sid=abBULtzvVl9c&refer=healthcare)

– Alpharma Inc.’s experimental morphine pill Embeda appears less susceptible to abuse than existing long- acting drugs for chronic pain, according to a majority of experts on a U.S. advisory panel.

A hidden chemical in Embeda called naltrexone may make it somewhat more difficult for abusers to get high by chewing or crushing the capsule, outside advisers to the Food and Drug Administration said at a meeting today in Gaithersburg, Maryland. While the panel didn’t take a vote, the FDA will consider the advice in deciding whether to approve the drug.

Support for Embeda helps Alpharma and King Pharmaceuticals Inc., which is trying to acquire the company in a $1.6 billion hostile takeover. They are among a half dozen drugmakers racing to introduce the first long-acting painkillers that are resistant to traditional methods of abuse. Embeda sales may reach $275 million by 2015, according to Ian Sanderson, a Cowen & Co. analyst.

“We have to start somewhere,” said panel member Nancy Nussmeier, professor and chair of anesthesiology at State University of New York Upstate Medical University. “It’s a small advance, but it’s an advance.”

Alpharma, of Bridgewater, New Jersey, rose $4.25, or 14 percent, to $34.75 at 4:15 p.m. in New York Stock Exchange composite trading. Bristol, Tennessee-based King fell 11 cents, or 1 percent, to $9.64.

The FDA is scheduled to act on Alpharma’s new drug application by Dec. 30 under a six-month “priority review” granted to drugs the agency deems to have significant benefits over existing therapies. The FDA usually follows its advisory panels’ recommendations, though it isn’t required to do so.

OxyContin Abuse

Regulators urged companies to develop tamper-resistant drugs after studies found that teenagers and adults were abusing controlled-released narcotics such as Purdue Pharma LP’s OxyContin. The closely held company from Stamford, Connecticut, agreed to pay $634.5 million last year to settle criminal and civil claims that it misled doctors about OxyContin’s risks from 1996 to 2001.

Yesterday, the majority of panel members spoke favorably of King and Pain Therapeutics Inc.’s Remoxy, designed to be a tamper-resistant version of the main ingredient in OxyContin.

Some members of the advisory panel said advertising Embeda or any new painkiller as abuse-resistant would only encourage misuse. Embeda’s core of naltrexone is activated when the drug is crushed or chewed, reducing the sense of euphoria given off by the morphine. It’s unclear whether injections or another form of manipulation would override the safeguard.

`No Perfect Solution’

“At the end of the day, we’re trying to make positive steps and not over-promise anything,” Joseph Stauffer, Alpharma’s chief medical officer, told the advisory panel. “There is no perfect solution and clearly this is not one either.”

The FDA won’t allow any drugmaker to claim that its product reduces abuse “until they prove it,” said Bob Rappaport, head of the FDA’s Division of Anesthesiology, Analgesia and Rheumatology Products, at the meeting. The agency may allow companies to include some data from their studies in prescribing information.

Embeda may capture 4 percent of prescriptions for controlled-released opium-like painkillers if it is approved, according to Sanderson, the Cowen analyst based in Boston. He raised his rating on Alpharma shares earlier today to outperform from neutral, citing the odds the panel would be supportive of Embeda and that the company would be bought by King, or an undisclosed rival bidder.

“Alpharma should outperform the market by 15 to 18 percent over the next several weeks,” Sanderson said today in a note to clients.

King’s takeover bid expires Nov. 21.

Bloomberg News, 11/15/08 (http://www.bloomberg.com/apps/news?pid=20601202&sid=aZ76ShNYr9_g&refer=healthcare)

 Eli Lilly & Co.’s antipsychotic Zyprexa and Novartis AG’s antifungal medicine Lamisil should be watched for potential risks in children, U.S. regulators said.

The Food and Drug Administration’s staff recommended adding new warnings to Zyprexa’s prescribing information about the risk of weight gain and other metabolic changes in children, side effects already noted for adults, according to safety reviews posted today on the agency’s Web site. The staff also called for investigations into cases of depression, suicidal thoughts and self-harm reported among patients taking Lamisil.

The reviews are required under the Best Pharmaceuticals for Children Act of 2002 for all drugs recently tested in children. Outside experts on the FDA’s Pediatric Advisory Committee will discuss the reports and make recommendations at a Nov. 18 meeting. Zyprexa, known chemically as olanzapine, is Lilly’s biggest drug with $4.76 billion in sales last year.

“No new safety signals emerged as part of this review; however, it has made us aware that the pediatric population is not spared from the adverse events caused by olanzapine therapy,” the FDA staff wrote. “The potential risks of olanzapine therapy should be weighed against the potential benefit when choosing to initiate therapy.”

The FDA is weighing whether to approve Zyprexa for patients 13 to 17 years old, said Lilly spokeswoman Marni Lemons in a telephone interview. The drug is currently approved for those 18 and older. Data from clinical trials on weight gain in younger patients is contained in the prescribing information.

Court Documents

Court documents obtained by Bloomberg News in July showed that Lilly trained its sales staff to downplay risks for Zyprexa and encourage doctors to prescribe the drug beyond its approved uses. Some patients gained as much as 80 pounds and had blood sugar 3.5 times higher than patients on a dummy pill, according to documents filed in a lawsuit brought by the state of Alaska. The company took a $1.48 billion charge in the third quarter to settle U.S. and state investigations into its Zyprexa marketing.

Lamisil lost patent protection in July 2007 and is now sold by several makers of generic drugs. Spokespeople for Novartis couldn’t be immediately reached.

USA Today, 11/17, reports, “Scientists are coming up with new ways to detect mild traumatic brain injury (TBI) and treat it,” according to findings presented at the Society for Neuroscience meeting.

For instance, Mingxiong Huang, of the University of California-San Diego, and colleagues, found that “by combining two advanced brain scanning techniques — MEG (magnetoencephalography) and DTI (diffusion tensor imaging) — they were able to discover brain injury that conventional MRI (magnetic resonance imaging) and CT had missed. The patients they diagnosed included people who were injured in mild explosions and sports-related accidents.”

Meanwhile, “University of Miami researcher Andrew Maudsley and colleagues reported that they used a new whole-brain method of magnetic resonance spectroscopic imaging (MRSI) to detect for the first time widespread brain damage that sometimes fails to show up in conventional brain scans of patients with mild to moderate TBI. MRSI is an advanced type of MRI that creates images from hundreds of voxels, three-dimensional units of brain tissue.”

HealthDay, 11/14/08 (http://www.healthday.com/Article.asp?AID=620988)

U.S. government scientists say they have developed a technology that can rapidly send an icy slush directly into the body to cool and to protect specific organs during certain health emergencies.

The “ice slurry” can be pumped easily into the body through a small intravenous catheter directly into a patient’s bloodstream. This cooling effect slows the demand for oxygen by the brain and other organs, giving doctors added time to diagnose and treat critical emergency cases or protect the heart, brain, kidneys and spinal cord in certain surgeries.

The developers, a team of scientists in the Nuclear Engineering Division at the U.S. Department of Energy’s Argonne National Laboratory, in conjunction with others from the University of Chicago, plan to seek U.S. Food and Drug Administration approval for using the technology in human trials. They have already successfully used the ice slurry in kidney surgeries conducted on large animals.

“Current medical guidance says that if you want to save the brain, you have to lower its temperature by four or five degrees Celsius within five to 10 minutes of cardiac arrest if paramedics can’t restart the heart,” engineer Ken Kasza, who led the development of the slurry production and delivery technology, said in a news release from the laboratory. “For the first time, we have a means of attaining the necessary temperature in that short span of time.”

During a cardiac arrest, for example, brain cells start to die in just minutes without oxygen from blood being pumped through the body. Within 10 to 20 minutes, the brain is dead.

Using the slurry technique for cardiac victims, the scientists said, would require the slurry to be delivered to the lungs through an endotracheal tube. Chest compressions could then be done to force blood through the cold lungs. From there, the chilled blood would pass through the carotid arteries and into the brain, cooling it rapidly.

This method would take only a few minutes while conventional cooling techniques, such as ice baths and cooling jackets, could take two hours to achieve the same effect. Also, the slurry’s ability to target selective organs cuts the risk of secondary adverse effects including shivering and possible arrhythmia, Kasza said.

Minimally invasive laparoscopic kidney surgery, cardiovascular surgery and surgeries that would otherwise risk neurological damage to the brain and spine are considered possible situations for the ice slurry to be used.

“In the emergency and surgical situations that we’re dealing with, time frequently is the most valuable resource we have,” Kasza said. “By understanding the complex interactions between the slurry and the vulnerable organs, we can optimally induce protective cooling and save lives.”

Bloomberg News, 11/15/08

Some people who received injections of dermal wrinkle fillers suffered “serious and unexpected” side effects, such as the loss of control facial muscles, disfigurement and rare life-threatening allergic reactions, U.S. regulators said Friday.

There were 930 reports of side effects of all types from January 2003 to Sept. 20 of this year for products made by various companies, according to a Food and Drug Administration staff review. The reports came from the U.S. and elsewhere.

FDA MedWatch, 11/17/08

CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The products were recalled because samples of the products were found to contain bacteria, Burkholderia Cepacia, formerly known as Pseudomonas Cepacia. There may be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. Consumers should discontinue using the product and should return it to the place of purchase. See the company’s press release for photos of product packaging.Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s recall press release at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Benzoyl