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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 10 of 10. This is the beginning of the thread.
Posted by steve on January 24, 1999, at 23:16:15
I've heard that an antidepressant is in the works that acts on Substance P. Any idea what this is or its mechanism of action?
Posted by Jack on January 25, 1999, at 3:55:33
In reply to Substance P drug???, posted by steve on January 24, 1999, at 23:16:15
It's called MK-869 by Merk, the company that's testing it. Substance P is a neuropeptide found in brain regions that control emotions. MK-869 is a Substance P inhibitor. Merk researchers claim that so far MK-869 has shown fewer side effects (ie. sexual) compared to most of what's available.
Posted by Annie on January 25, 1999, at 7:13:23
In reply to Substance P drug???, posted by steve on January 24, 1999, at 23:16:15
I took part in one of the studies. It didn't work for me, but I was hopeful for others. Unfortunately, it must not have worked for many others. See article below:
Merck Ends Testing of Substance P Depression Drug
-- Merck & Co., the world's biggest drugmaker, halted tests of an experimental antidepressant it was counting on to help make up for loss of patent protection on some of its best-selling drugs.Merck fell 7 5/16 to 139 after it announced the end of testing for MK-869 drug against depression. Early studies didn't provide enough evidence the drug works as an anti-depressant. Instead, Merck will continue testing it for use in nausea in cancer patients.
The drug, which works on a brain chemical known as substance P, was seen as one of Merck's best prospects for offsetting the loss of patents by 2001 on four drugs with more than $5 billion in combined annual sales. These drugs include Vasotec with more than $2 billion in annual sales.
``It's a major setback for Merck,'' said Mike Krensavage, an analyst with Brown Brothers Harriman, who has a short-term ``neutral'' rating on Merck. ``The insurance policy they were going to use against the patent exposures has been canceled.''
Merck has said it intends to rely on its own laboratories and its alliances with smaller partners to come up with the new products needed to get through the patents losses. Some of Merck's rivals, such as Astra AB, instead are merging with other drugmakers as patent losses near.
Still, analysts have not been impressed with the new products Merck has introduced recently. Merck started sales of five new medicines in 1998, including the once-a-day asthma medicine Singulair, the anti-baldness pill Propecia and heart drug Aggrastat. Although Singulair has done well, this crop of new drugs might not provide an immediate replacement for Vasotec's sales.
Merck Vulnerable
``Merck's in a very vulnerable position,'' said Alex Zisson, an analyst with Hambrecht & Quist, who has a ``neutral'' rating on Merck. ``Some of their launches, like Propecia and Aggrastat, haven't done well.''
Now, Merck is looking to one drug alone, its experimental painkiller Vioxx, analysts said. Vioxx, which is waiting for U.S. approval, is part of a new class of drug that appear to treat pain and inflammation without irritating the stomach as does aspirin and other painkillers.
Rival Monsanto Co. last month won U.S. Food and Drug Administration approval of a similar drug, Celebrex. It intends to introduce the drug in late February, although doctors already are writing prescriptions for it.
Relying on Vioxx
``Without MK-869, Merck will have to rely even more on Vioxx and it's not good,'' to depend so much on one product, Krensavage said.
Not only does Monsanto have a head start on Merck, Monsanto has chosen a marketing partner, Pfizer Inc., that already has beaten Merck in the marketing battle for a key drug.
Pfizer, which will work with Monsanto to sell Celebrex, also helps Warner-Lambert Co. sell its cholesterol-reducing drug Lipitor. Pfizer's assistance helped make Lipitor's 1997 introduction the best ever in the U.S. drug industry, a record broken only by the 1998 introduction of Pfizer's impotence pill Viagra.
Merck halted testing of MK-869 after the second of three phases of testing needed to apply for U.S. Food and Drug Administration approval of a drug.
In a release, the company said phase II trials of the compound ``suggest'' it has anti-depressant activity, but that the drug's effect was not significantly better than the effect seen with a placebo sugar pill.
Merck's earlier studies had led investors and analysts to speculate the drug might someday rival some of the world's top- selling drugs, such as SmithKline Beecham Plc's Paxil. Depression drugs are among the world's top-sellers. Eli Lilly & Co.'s Prozac has annual sales of more than $2 billion.
``It's not good news, to say the least,'' said Hemant Shah, an independent pharmaceutical analyst. ``This was regarded by many analysts as the next big multibillion-dollar drug, mostly because of its depression use,'' he said.
Building Expectations
Merck began building expectations for MK-869 in December 1997, taking the unusual step of highlighting early research about the compound at its analyst meeting. Merck touted its experimental drug ``as better than Prozac,'' Shah said.
Merck said today in a release that as it pursues development of MK-869 for nausea, it will continue early trials of a different, more potent compound that has shown promise in treating depression.
A study published this week in the prestigious New England Journal of Medicine found MK-869 to be effective at neutralizing the waves of nausea and vomiting that most often strike cancer patients as they are undergoing chemotherapy.
> I've heard that an antidepressant is in the works that acts on Substance P. Any idea what this is or its mechanism of action?
Posted by Elizabeth on January 26, 1999, at 10:22:51
In reply to Re: Substance P drug???, posted by Annie on January 25, 1999, at 7:13:23
The latest rumor that I've heard (well, actually it was a Reuters article) is that Merck regards the problems in the MK-869 depression trials to stem not from problems with the drug itself but from a high placebo response rate.
They were comparing MK-869 to Paxil and placebo, and the placebo response rate was so high that Paxil appeared to be no better than the placebo. (Merck appeared to be blaming Paxil for this, but anyway....)
I'd like to see the results of the various individual trials that were conducted at various sites.
They are going to continue with the Substance P antagonist train of research, but will be using a different drug in future studies. However, this sets them back a year or so, at least.
Posted by Annie on January 26, 1999, at 15:33:22
In reply to Re: Substance P drug???, posted by Elizabeth on January 26, 1999, at 10:22:51
When i was part of a MK0869 trial, the alternate drug used was Prozac, not Paxil. Perhaps they gave up on Paxil toward the end. This trial was in September.
Posted by Tarolyn Snead on February 3, 1999, at 12:15:44
In reply to Re: Substance P drug???, posted by Annie on January 25, 1999, at 7:13:23
>Please let me know where this article on Substance P came from. I am doing a seminar on antidepressants
in development, especially MK-869. Thanks!
I took part in one of the studies. It didn't work for me, but I was hopeful for others. Unfortunately, it must not have worked for many others. See article below:
> Merck Ends Testing of Substance P Depression Drug
>
> -- Merck & Co., the world's biggest drugmaker, halted tests of an experimental antidepressant it was counting on to help make up for loss of patent protection on some of its best-selling drugs.
> Merck fell 7 5/16 to 139 after it announced the end of testing for MK-869 drug against depression. Early studies didn't provide enough evidence the drug works as an anti-depressant. Instead, Merck will continue testing it for use in nausea in cancer patients.
> The drug, which works on a brain chemical known as substance P, was seen as one of Merck's best prospects for offsetting the loss of patents by 2001 on four drugs with more than $5 billion in combined annual sales. These drugs include Vasotec with more than $2 billion in annual sales.
> ``It's a major setback for Merck,'' said Mike Krensavage, an analyst with Brown Brothers Harriman, who has a short-term ``neutral'' rating on Merck. ``The insurance policy they were going to use against the patent exposures has been canceled.''
> Merck has said it intends to rely on its own laboratories and its alliances with smaller partners to come up with the new products needed to get through the patents losses. Some of Merck's rivals, such as Astra AB, instead are merging with other drugmakers as patent losses near.
> Still, analysts have not been impressed with the new products Merck has introduced recently. Merck started sales of five new medicines in 1998, including the once-a-day asthma medicine Singulair, the anti-baldness pill Propecia and heart drug Aggrastat. Although Singulair has done well, this crop of new drugs might not provide an immediate replacement for Vasotec's sales.
> Merck Vulnerable
> ``Merck's in a very vulnerable position,'' said Alex Zisson, an analyst with Hambrecht & Quist, who has a ``neutral'' rating on Merck. ``Some of their launches, like Propecia and Aggrastat, haven't done well.''
> Now, Merck is looking to one drug alone, its experimental painkiller Vioxx, analysts said. Vioxx, which is waiting for U.S. approval, is part of a new class of drug that appear to treat pain and inflammation without irritating the stomach as does aspirin and other painkillers.
> Rival Monsanto Co. last month won U.S. Food and Drug Administration approval of a similar drug, Celebrex. It intends to introduce the drug in late February, although doctors already are writing prescriptions for it.
> Relying on Vioxx
> ``Without MK-869, Merck will have to rely even more on Vioxx and it's not good,'' to depend so much on one product, Krensavage said.
> Not only does Monsanto have a head start on Merck, Monsanto has chosen a marketing partner, Pfizer Inc., that already has beaten Merck in the marketing battle for a key drug.
> Pfizer, which will work with Monsanto to sell Celebrex, also helps Warner-Lambert Co. sell its cholesterol-reducing drug Lipitor. Pfizer's assistance helped make Lipitor's 1997 introduction the best ever in the U.S. drug industry, a record broken only by the 1998 introduction of Pfizer's impotence pill Viagra.
> Merck halted testing of MK-869 after the second of three phases of testing needed to apply for U.S. Food and Drug Administration approval of a drug.
> In a release, the company said phase II trials of the compound ``suggest'' it has anti-depressant activity, but that the drug's effect was not significantly better than the effect seen with a placebo sugar pill.
> Merck's earlier studies had led investors and analysts to speculate the drug might someday rival some of the world's top- selling drugs, such as SmithKline Beecham Plc's Paxil. Depression drugs are among the world's top-sellers. Eli Lilly & Co.'s Prozac has annual sales of more than $2 billion.
> ``It's not good news, to say the least,'' said Hemant Shah, an independent pharmaceutical analyst. ``This was regarded by many analysts as the next big multibillion-dollar drug, mostly because of its depression use,'' he said.
> Building Expectations
> Merck began building expectations for MK-869 in December 1997, taking the unusual step of highlighting early research about the compound at its analyst meeting. Merck touted its experimental drug ``as better than Prozac,'' Shah said.
> Merck said today in a release that as it pursues development of MK-869 for nausea, it will continue early trials of a different, more potent compound that has shown promise in treating depression.
> A study published this week in the prestigious New England Journal of Medicine found MK-869 to be effective at neutralizing the waves of nausea and vomiting that most often strike cancer patients as they are undergoing chemotherapy.
>
> > I've heard that an antidepressant is in the works that acts on Substance P. Any idea what this is or its mechanism of action?
Posted by Annie on February 5, 1999, at 17:45:21
In reply to Re: Substance P drug???, posted by Tarolyn Snead on February 3, 1999, at 12:15:44
I'm sorry the only other information I have on this article which was posted on an investment message board, is that it originated at Bloomberg.com on January 22,1999. I would suggest that you go to Merck's homepage and check for January press releases. Good Luck with your seminar.
Posted by Theresa Waldron on February 7, 1999, at 18:23:46
In reply to Re: Substance P drug???, posted by Jack on January 25, 1999, at 3:55:33
Recently, Merck announced it will drop further studies of substance P for depression because one arm of a phase II trial didn't work out. Instead, they're going to study it for chemotherapy-induced nausea and vomiting, for which it does seem to be effective.
Posted by Victoria on February 23, 1999, at 21:04:46
In reply to Re: Substance P drug???, posted by Theresa Waldron on February 7, 1999, at 18:23:46
I'm surprised that Merck isn't testing the Substance P drug for fibromyalgia, for which there is a documented dysfunction of
substance P. There's no widely effective treatment for fibromyalgia (although anti-depressants often help) and lots of people with it!
> Recently, Merck announced it will drop further studies of substance P for depression because one arm of a phase II trial didn't work out. Instead, they're going to study it for chemotherapy-induced nausea and vomiting, for which it does seem to be effective.
Posted by Elizabeth on February 25, 1999, at 16:42:50
In reply to Re: Substance P drug???, posted by Victoria on February 23, 1999, at 21:04:46
> I'm surprised that Merck isn't testing the Substance P drug for fibromyalgia, for which there is a documented dysfunction of
> substance P. There's no widely effective treatment for fibromyalgia (although anti-depressants often help) and lots of people with it!Are there widely agreed-upon diagnostic criteria for fibro? If not, that could make it very difficult to test a drug for it. Although, paradoxically perhaps, a drug with a specific indication for fibro might result in the disorder being better recognized and accepted by the medical community.
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