Does Pfizer Have A Multibillion-Dollar Replacement For Opioids?

https://www.investors.com/news/technology/pfizer-lilly-tanezumab-opioids-treating-pain/

“In our 2019 preview we said the biggest surprise could be that the safety for Pfizer and Lilly’s tanezumab will be better than expected, and this drug could replace opioids for the treatment of pain,” Cantor Fitzgerald analyst Louise Chen said in a report to clients.

Chen kept her overweight rating and 53 price target on Pfizer stock. On the stock market today, Pfizer stock advanced 1.6% to close at 43.65. Meanwhile, Lilly stock lifted 1.3%, to 115.72.

Combating Opioids In Treating Pain

One estimate suggests that more than 115 people die each day in the U.S. after overdosing on opioids. The Centers for Disease Control and Prevention estimates the total economic burden of prescription opioid misuse in the U.S. is $78.5 billion annually.

Pfizer and Lilly’s tanezumab could help ease the opioid crisis, Chen says.

“If we are right, then the peak sales potential of tanezumab could be billions of dollars,” she said. This would “drive upside to modest expectations for the drug.”

Pfizer and Lilly expect to release study results within six months on treating osteoarthritis pain. The results will examine 24 weeks and 56 weeks of treatment. The companies will also release the results of a study in chronic low back pain.

Safety Questions For NGF Inhibitors

But questions persist around nerve growth factor, or NGF, inhibitors like tanezumab. In early tests, the drugs have been connected to abnormal joint damage. Regeneron Pharmaceuticals (REGN) and Teva Pharmaceutical (TEVA) have another NGF called fasinumab.

Earlier this year, Pfizer and Lilly said 1.3% of patients given tanezumab in a 16-week test showed problematic joint damage, known as rapidly progressive osteoarthritis, or RPOA. There were no cases of RPOA in patients who received the placebo.

Investors expect the upcoming results to be “similar to or worse” than prior data, Cantor Fitzgerald’s Chen said.

“However, physicians we interviewed were impressed by that data, and did not believe the RPOA imbalance would impact their desire to prescribe tanezumab, if it is approved,” she said.

Tanezumab – FDA Allows Trials To Continue On This Horror Drug

Tanezumab was going to be Pfizer’s next cash cow. It was one of a new class of anti-nerve growth factor (anti-NGF) drugs, which blocks a key protein that helps deliver your body’s pain signals.

So when people with severe joint pain enrolled for tanezumab trials, they were desperately searching for relief. Even though the drug was still in its experimental phase, it was supposed to be safe and promised to melt away even the most agonizing joint pain.

However, as soon as the tanezumab trials began the horror show also started… people were left with permanent joint damage and others were scrambled into surgery for new knees, hips and shoulders.

Researchers reported fractures and total joint collapse among participants and even the American Food and Drug Administration (FDA) said it looked more like participants were developing “rapidly progressive arthritis” causing “death of bone tissue due to a lack of blood.”

A second season of the tanezumab horror show

Finally, in 2012, after tanezumab unleashed endless suffering onto patients the FDA was forced to bring all trials for anti-NGF drugs to an immediate halt. In the aftermath a top researcher testified that it would be unethical to ever resume human testing of tanezumab again.

As we all know, ethics are not Big Pharma’s strongest characteristic… and now, a mere three years after the first tanezumab horror season, Pfizer is picking up right where it left off ready for a tanezumab sequel along with a $2 billion investment from its new partner, the pharmaceutical company Eli Lilly.

And it looks like these two powerful drug companies are happy to spend – and say – anything to unleash this risky drug on a new round of victims.

The FDA recently announced that it would allow tanezumab trials to resume after new “nonclinical” data (as in research that did not come from the previous, disastrous trials) showed tanezumab “could be safe”.

Now, when it comes to pharmaceutical drugs, those three words should be enough to send the red flags flying and the alarm bells ringing.

But as a result of the fancy footwork Pfizer and Eli Lilly are using to explain away the bone and joint damage the drug has done in previous trials, joint pain sufferers are in for a second round of tanezumab hell.

See, the researchers claim that tanezumab was so effective in previous trials and took away so much pain that the participants using it weren’t “signalled” that they were overusing their fragile bones.

That’s right, blame the participants!

It’s an excuse that’s impossible to believe – especially because in one trial, a full third of tanezumab patients didn’t experience any clinically significant pain relief at all.

Frankly, tanezumab is a blunder drug, not a wonder drug.

But the FDA swallowed the explanation hook, line and sinker, and not before long tanezumab will be sent to the FDA for final approval.

Unfortunately, we know that people will be tricked into participating in new tanezumab trials, lured by the same empty promises that were made just three years ago. It’s doubtful they’ll be warned before they sign away their rights – and their joints – on the dotted line.

We can’t stop tanezumab from hitting the market, but we can let you know when it gets approved and under what brand names it will be sold so that you can be sure to avoid this drug at all costs.

Filed under: General Problems