A drug known for its “depression hurts” advertisements increasingly is being deployed by doctors to treat chronic pain.
Cymbalta is a go-to drug of near-last resort for many patients who have battled pain at length and received little relief from anti-inflammatory drugs, muscle relaxants, physical therapy and other treatments.
It's not widely known that physicians have prescribed antidepressants for pain for years. They do so not because the patient is necessarily depressed, although he may be dejected because of the pain. They do it mainly because a drug like Cymbalta blocks pain signals traveling back and forth among body, spine and brain.
Cymbalta became the only antidepressant approved by the Food and Drug Administration for chronic musculoskeletal pain, such as lower back pain and arthritic joints, in late 2010. Global sales increased to more than $1.3 billion in the first quarter of this year, up 35 percent from the last quarter of 2010.
For individual patients, the cost can be $50 a month or more for the drug even with insurance, and $250 to $300 a month without insurance. But there is uplifting news for them. The patent owned by the parent company, Eli Lilly & Co., is expected to expire at the end of this year, meaning generic versions should crop up eventually.
Rebecca Johnston of La Vista has had both knees replaced, a shoulder joint worked on and her lower back fused. Worst of all, a railing on her deck gave way in 2002 as she leaned to toss a treat to the neighbors' dogs. She crashed headfirst to the ground, breaking her neck.
Johnston, now 70, suffered no paralysis, but surgeons had to work extensively on her spine. The soreness in her neck, back and artificial joints grew intense.
“When they ask you the pain level, 1 to 10, I always said 100,” Johnston recalled. Medications didn't provide relief.
But when her physician, Dr. Angie Rakes, a pain specialist at the University of Nebraska Medical Center, put Johnston on Cymbalta about five years ago, she felt less pain within a few days. She remains on the drug. She still suffers soreness, especially on rainy and snowy days. She receives an occasional injection to relieve pain in her neck. But Johnston testifies that Cymbalta has made a difference, without side effects.
“It's been really helpful to me,” she said. “It knocks it (the pain) down pretty good.”
Johnston also has the good fortune of only having to pay about $24 a month for Cymbalta under her insurance plan.
Cymbalta, which has the scientific name duloxetine, previously had been approved for depression, anxiety, diabetic nerve pain and fibromyalgia. Some other antidepressants, such as the generic nortriptyline, also are used for pain.
Dr. John Massey, a pain specialist with Lincoln-based Spine & Pain Centers of Nebraska, said Cymbalta isn't used for acute pain, when tissue or bone are injured. The drug comes into play when the nerves won't quiet, even after healing has occurred.
Although scientists don't fully know how it works, he said, Cymbalta restores the body's ability to shut down pain signals when they're no longer valid. Many patients will be on the drug for the long haul.
Doctors have used antidepressants legally “off label” — for a use not formally approved by the FDA — for chronic pain for at least 20 years, said Dr. Chris Criscuolo, a pain specialist with Alegent Creighton Health. “This is not anything new.”
But based on the word of some pain specialists and drug sales, Cymbalta is perhaps the preferred antidepressant for pain. Cymbalta was the third-leading drug in sales in the first quarter of 2013, according to the website drugs.com.
“It's been an excellent drug,” said Dr. Lynn Webster, a Utah physician and president of the American Academy of Pain Medicine.
Webster said that while patient reactions to drugs vary widely, Cymbalta generally has had fewer side effects than generics such as amitriptyline, an antidepressant that has been used for pain for a long time.
Rakes said Cymbalta nevertheless may have side effects, including weight gain. Other potential side effects include headaches, itching, high fever and racing heart.
Rakes said she doesn't start patients with Cymbalta but has them try physical therapy, other pain medications and pain injections before moving on to Cymbalta.
The drug is expensive, she said, and not all insurance plans cover it. But she has “hit a lot of home runs” with it, she said, prescribing it with good results to people with arthritic joints who couldn't otherwise get relief.
“Oh yes, my patients are waiting for it” to go to generic, Rakes said.
A Kohll's Pharmacy & Homecare spokeswoman said out-of-pocket costs for Cymbalta for an insured patient may be $50 or more, depending on the plan. Generics of all kinds cost $3 and up, said the spokeswoman, Laurie Dondelinger.
A Lilly's spokeswoman said through an email: “We believe our medicines are priced fairly in the market and reflect the tremendous resources required to discover and develop new medicines and the need to recoup those costs to fund the much-needed research to develop new medicines.”
She said Lilly's U.S. market exclusivity for Cymbalta will expire in December.
Dr. Bartholomew Clark, associate professor of pharmacy sciences at Creighton University, said Lilly might produce an “authorized generic” for six months next year, during which time the price likely would remain close to the brand-name price.
After that, though, prices should fall as other manufacturers produce generic versions of duloxetine. How many join the competition is unknown, but Cymbalta's sales should make generic production appealing.
“It's really just supply and demand,” Clark said. The FDA says a generic must use the same active ingredients as the brand-name drug and be comparable in quality, performance, strength and route of administration.
Bob Amey wants a generic version.The 55-year-old factory worker from Table Rock, Neb., had a cancerous lung removed in 2009. His chest became infected, and he had to be opened up again. The surgeries caused nerve damage on the right side of his body, and he suffered severe pain. He couldn't hug his wife or hold his grandchildren without pain. It hurt if his shirt flapped through a car window.
Pain medication didn't touch his misery. He became hooked on prescription morphine and was, he said, “a doped idiot laying in the chair.”
His family physician eventually prescribed Cymbalta. Massey, the Lincoln-based pain specialist, supplemented Cymbalta with pain patches and a nerve-pain drug called Lyrica. Now Amey can walk for exercise, do situps and pushups, and hug his loved ones.
Amey pays about $100 a month for the pain medications and is on disability income. But he's no longer miserable.
“It's been a long and tough road,” he said. “By God, I'm glad I'm on the right side of the dirt.”