3 Revolutionary Drugs for Chronic Pain

Flexion Therapeutics, Cara Therapeutics, and Nektar Therapeutics have entirely new ideas for how to treat chronic pain, and those ideas may reshape the market.

Flexion Therapeutics (NASDAQ:FLXN), Cara Therapeutics (NASDAQ:CARA), and Nektar Therapeutics (NASDAQ:NKTR) may soon offer patients suffering from chronic pain a better option than opioids. Here's how these companies plan to reshape the way doctors treat the 39 million Americans with chronic pain.

Tackling knee pain

Flexion Therapeutics' Zilretta is under review by the Food and Drug Administration (FDA) as a new approach to treating knee pain caused by osteoarthtritis, and positive results from trials suggest it could eventually replace corticosteroid injections for millions of patients.

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The FDA will issue a go/no-go decision on Zilretta on Oct. 6, and data from studies may be compelling enough for a green light. In trials, Zilretta patients enjoyed a median 50% reduction in knee pain, and, more importantly, that pain relief was maintained throughout a three-month period. If Zilretta's effectiveness holds up in the real world, there's a good chance it will win support with doctors and patients because pain relief from corticosteroids typically wears off within weeks -- long before the next scheduled quarterly injection.

Roughly 5 million people currently receive corticosteroid shots because of their pain, and management thinks Zilretta could fetch $2,000 per patient per year. If this estimate is on target, it won't take a lot of market share for Zilretta to be a top seller. 

Recently, rumors have surfaced that acquisition-hungry Sanofi SA (NYSE:SNY) is kicking Flexion Therapeutics' tires. It wouldn't shock me if those rumors are true. Sanofi has attempted to buy Medivation and Actelion in the past year, so it's clearly on the hunt for acquisitions. Importantly, Sanofi already markets Synvisc-One -- a hyaluronan injection used to treat knee pain -- which generates $400 million per year, so it's already got the sales force in place to turn Zilretta into a winner. 

Outperforming opioids

Cara Therapeutics thinks CR845's ability to relieve pain with less risk of addiction could allow it to capture a big share of the 24 million pain prescriptions written for opioids every year.

Instead of targeting mu-opioid receptors in the nervous system like opioids, CR845 relieves pain at the source by targeting kappa-opioid receptors in the periphery of the body. Because CR845 is designed not to pass easily through the blood-brain barrier, it delivers less of a euphoric high than opioids.

CR845 is being studied in hip and knee pain in osteoarthritis patients, and management just reported data showing that it can help reduce chronic itch in dialysis patients.

The potential to elbow market share away from opioids and deliver greater relief to dialysis patients is exciting, but more trials are required before Cara Therapeutics can file for FDA approval of CR845. Because more work needs to be done, it may be a while before this drug makes it to market. Nevertheless, this company's opportunity is big, and that makes tracking its progress worthwhile.

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Improving the standard

Like CR845, Nektar Therapeutics' NKTR-181 may eventually reduce pain patients' need for opioids. But, unlike CR845, NKTR-181 still targets mu-opioid receptors in the nervous system to deliver pain relief.

However, it does so selectively. And it's specifically designed to cross the blood-brain barrier slowly to reduce euphoria. By more precisely targeting the receptors and limiting euphoria, it may deliver similar relief to opioids with less of a risk of abuse.

Last week, the company announced results from a trial testing NKTR-181 for chronic back pain, and that trial's data didn't disappoint. NKTR-181 reduced pain relative to a placebo, and it did so without causing opioid-like levels of euphoria.

Those findings sent Nektar Therapeutics shares soaring, but the company hasn't announced its plans to file for FDA approval yet. Instead, management is searching for a bigger peer to partner with on the drug. Assuming it secures a deal, an FDA filing should come shortly thereafter, with an official regulatory decision coming 10 months later.

Todd Campbell

Source: https://www.fool.com/investing/2017/03/30/3-revolutionary-drugs-for-chronic-pain.aspx?yptr=yahoo

How High Can Cara Therapeutics Stock Go?

Cara Therapeutics stock is soaring. Can the biotech's huge momentum continue -- and, if so, for how long?


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In just six weeks, Cara Therapeutics' (NASDAQ:CARA) shares have skyrocketed by roughly 80%. The stock has more than doubled since the beginning of November. Did Cara report great results from a clinical trial? Nope. Investors simply seem to have gained an intense interest in the clinical-stage biotech.

There are several potential catalysts coming up this year that could give investors solid reasons to like Cara Therapeutics even more. The real question, though is this: How high can this biotech's stock really go?

What's intriguing investors

Cannabinoid Receptor Agonists

There have been plenty of news stories about the opioid epidemic sweeping the United States. Opioid drugs are great at helping reduce pain, but they're also very addictive. At least most of them are. But not all. That's where Cara Therapeutics comes into play.

Cara's lead product, CR845, is a kappa opioid agonist. Most of the opioid drugs you're probably familiar with, like morphine, oxycodone, and hydrocodine, bind to mu opioid receptors in the body's central nervous system. CR845, however, targets kappa opioid receptors in peripheral nerve cells outside of the central nervous system. Because the drug doesn't enter the brain, it has the potential to relieve pain without causing the negative side effects associated with many existing opioid drugs.

The biotech is targeting three indications with CR845: post-operative pain, chronic pain, and pruritus (itching). Phase 2 clinical results for the experimental drug in treating post-operative pain after hysterectomies were very encouraging. Patients taking CR845 experienced significantly lower post-op pain levels and reduced post-op use of narcotics.

Cara also reported great results from a phase 2 study of CR845 in treating chronic pain. Patients taking a 5 mg dose of the drug experienced significantly less pain and required less rescue medications (drugs needed for immediate pain relief) than those on placebo.

It was a similar story for Cara's phase 2 study targeting uremic pruritis, an internal itching that is caused by chronic kidney failure. Patients taking CR845 reported significantly reduced itch intensity than did patients on placebo. The patient receiving CR845 also reported significantly better quality of life scores. 

Coming catalysts

More good news could be on the way for Cara Therapeutics. The biotech has three key data readouts scheduled for 2017.

Cara expects to announce top-line results from its late-stage study evaluating CR845 administered intravenously in treating acute post-op pain in the first half of this year. These results will be enormously important for the company. If things go well, Cara could file for regulatory approval based on the study.

Top-line results from the company's phase 2/3 clinical study of intravenous CR845 in treating uremic pruritus are expected by the end of the first quarter. This phase involved 160 patients treated for eight weeks. The next phase of the study will include 240 patients with a treatment period of 12 weeks.

Another key announcement is also expected in the first half of 2017. Cara should report top-line results from its phase 2 study evaluating an oral form of CR845 in treating patients with chronic osteoarthritis pain. 

Lots of opportunity

There's certainly a large potential market for CR845 if it wins approval. Take the post-op pain indication, for example. Around 46 million inpatient and 53 million outpatient surgeries are performed each year in the U.S. Over 200 million prescriptions are filled annually for drugs to manage pain outside of the hospital setting.

The chronic pain market is also a big opportunity. More than 100 million prescriptions are dispensed each year in the U.S. for drugs to treat patients with chronic pain.What about the potential uremic pruritus market? Over 20 million Americans take prescription drugs for treating the condition. 

Of course, Cara won't capture all of the potential market even assuming CR845 wins regulatory approval. Dislodging existing drugs won't be an easy task even with some of the advantages offered by the kappa opioid agonist.

Cara could also face stiff competition from another new entrant to the market -- Trevena (NASDAQ:TRVN). Although Trevena's lead candidate, oliceridine, targets the mu opioid receptors like most opioids available today, there's a twist. Oliceridine selectively activates pain-relieving pathways while avoiding the pathway associated with the adverse effects typically experienced with opioid drugs.

Trevena could get a slight head start on Cara as well. The biotech expects to announce results from its late-stage study of oliceridine as a treatment for moderate-to-severe acute post-op pain in the first quarter of 2017. If those results are positive, Trevena plans to submit for U.S. regulatory approval in the second half of this year.

How high?

Cara Therapeutics' market cap soared to over $450 million thanks to the huge stock run-up in recent months. Although there are always risks, I think the potential for CR845 to ultimately win approval for all three indications the biotech is targeting looks pretty good. 

I wouldn't be surprised if Cara becomes an acquisition target by a larger company with an established sales force in the pain market. Even without the buyout possibility, though, my view is that the coming catalysts this year should spur Cara's shares to go even higher. Another jump of 30% or perhaps more by the end of 2017 doesn't seem unrealistic.  

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Source: https://www.fool.com/investing/2017/02/12/how-high-can-cara-therapeutics-stock-go.aspx?source=yahoo-2&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2&yptr=yahoo