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APNews: Startup could bring back Vioxx for hemophilia

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TRENTON, N.J. (AP) — Could there be a second life for the once-popular arthritis pill Vioxx? A startup pharmaceutical company hopes so.

Merck & Co. voluntarily pulled the blockbuster drug in 2004 amid evidence that it doubled the chances of having a heart attack or stroke.

Now tiny Tremeau Pharmaceuticals is working to bring back it back, to treat severe joint pain caused by the bleeding disorder hemophilia. That’s for far fewer patients than the millions who took Vioxx pills for arthritis and other chronic pain — but if it’s approved doctors could again legally prescribe it to anyone.

Many hemophilia patients rely on opioid painkillers because nearly every other pain reliever increases the risk of internal bleeding. Considerable research shows Vioxx doesn’t do that.

“It seemed to me that there was a huge unmet medical need” for these patients, Brad Sippy, Tremeau’s chief executive, told The Associated Press. He put together a plan and co-founded Tremeau last year to develop nonopioid pain treatments for rare diseases.

A longtime pharmaceutical marketing executive, Sippy worked at Merck during the Vioxx era and helped with its recall from pharmacy shelves. He also knew the final patent protecting Vioxx’s monopoly was expiring this fall.

When it stopped making Vioxx, Merck was facing thousands of lawsuits from people claiming the drug caused their heart attacks or strokes. Merck’s own research showed the drug doubled those risks, but lawyers for patients claimed the company downplayed or concealed that. Merck initially fought the lawsuits but in 2007 agreed to a $4.85 billion settlement.

If Tremeau gets approval in a few years to start selling rofecoxib, the chemical name for Vioxx, doctors could prescribe it to other people with garden-variety chronic pain. Tremeau wouldn’t be able to legally promote those unapproved uses, but some patients likely would want it. Vioxx was so effective that some users hoarded it after Merck took it off market.

“I know a lot of people who swore by Vioxx,” said analyst Steve Brozak, president of WBB Securities. “Repurposing this for the hemophilia community is particularly brilliant.”

Dr. Steven Stanos, president of the American Academy of Pain Management, a professional group for pain specialists, said it made sense to try Vioxx for hemophilia joint pain.

“Vioxx was very potent,” he said.

The drug would still carry a strong warning about heart attack and stroke risks. Doctors would have to balance its pain benefit against each patient’s risks, Stanos said.

On Tuesday, Tremeau was announcing that the Food and Drug Administration recently handed it an endorsement of sorts: an orphan drug designation. That’s for disorders affecting fewer than 200,000 Americans, and comes with benefits, including tax credits on testing costs and a free FDA review.

Still, it’s no slam-dunk. Sippy said the Cambridge, Massachusetts-based Tremeau must raise $25 million or more to pay for testing in hemophilia patients. Then the results must be good enough for FDA approval.

In the U.S., just over 20,000 people have hemophilia, an inherited disorder that leaves them without key proteins in the blood needed for clotting. The slightest injury can trigger uncontrolled internal bleeding. Since the 1990s, most patients have been getting medicine that limits but doesn’t prevent all bleeding episodes. Blood buildup in the joints can damage them and cause pain.

“Without other options, opioids are often the next step” after Tylenol, sometimes at high doses, said Dr. Stacy Croteau of the Boston Hemophilia Center, who is a paid consultant for Tremeau. “Rofecoxib would hopefully allow us to reduce use of opioids.”

Meanwhile, Tremeau is deciding on the drug’s brand name. Sippy said the Vioxx name, no longer protected by trademark, might scare some people, while others would remember its effectiveness.

“We haven’t excluded it,” he said.

 

Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

HHS Acting Secretary Declares Public Health Emergency to Address National Opioid Crisis

Acting Health and Human Services (HHS) Secretary Eric D. Hargan issued the following statement upon declaring a nationwide public health emergency regarding the opioid crisis: “Today’s declaration, coupled with the President’s direction that executive agencies use all appropriate emergency authorities and other relevant authorities, is another powerful action the Trump Administration is taking in response to America’s deadly opioid crisis."

https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html

Steps the U.S. government should take right now against the opioid epidemic

Among the recommendations to address the opioid epidemic, authors Andrew Kolodny, MD and Thomas R. Frieden, MD, MPH propose:

"Increase insurance coverage of and access to nonopioid and nonpharmacological management of pain. Chronic pain is a serious and potentially disabling problem for millions of people in the United States. Opioids are likely less effective and certainly more dangerous than other modalities of chronic pain management. The Centers for Medicare & Medicaid Services should ensure full reimbursement for nonprescription analgesics, such as acetaminophen and nonsteroidal anti-inflammatory drugs, for Medicare Part D and Medicaid beneficiaries. This would remove a financial disincentive for patients to use these medications. Easier access to and low or no copayments for physical therapy and other nonpharmacological pain management modalities could potentially reduce medication use and improve patient functionality and outcomes."

https://jamanetwork.com/journals/jama/fullarticle/2657452

 

FDA is committed to new classes of pain medicines without the same risks as opioids

Issue: Addressing the lack of non-opioid alternatives for pain management.Although non-opioid medications for chronic pain have recently been approved for the market, more alternatives are needed, including non-pharmacologic treatments.

The FDA is working closely with industry and the National Institutes of Health to develop alternative medications without the addictive properties of opioids. Nonpharmacologic approaches to paintreatment have also been identified as an urgent priority.
— Robert M. Califf, M.D., Janet Woodcock, M.D., and Stephen Ostroff, M.D.

Use and frequency of oral opioids are the greatest predictor of subsequent opioid addiction

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4767561/pdf/nihms752582.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4767561/pdf/nihms752582.pdf

The opioid epidemic is an escalating public health crises that require a public health response proportionate in scale. Our results suggest that preventing transition to non-oral pharmaceutical opioid use, preventing transition to opioid dependence (by reducing/ maintaining (or eliminating) frequency of PO use), and educating PO users about the risks involved in reasons for use among those non-opioid dependent are important intervention targets

Since 2011, more than 16,000 people in the US have died each year from Rx Opioid Overdose

https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/national-overdose-deaths2015.pdf

https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/national-overdose-deaths2015.pdf

National Overdose Deaths—Number of Deaths from Prescription Opioid Pain Relievers (excluding non-methadone synthetics). The figure above is a bar chart showing the total number of U.S. overdose deaths involving opioid pain relievers (excluding non-methadone synthetics) from 2002 to 2015. Non-methadone synthetics is a category dominated by illicit fentanyl, and has been excluded to more accurately reflect deaths from prescription opioids. The chart is overlayed by a line graph showing the number of deaths of females and males. From 2002 to 2011 there was a 1.9-fold increase in the total number of deaths, but it has remained relatively stable since then.