Merck

22 August 2016

Ubrogepant (another migraine drug in development)

The development of the new CGRP class of drugs (actually, calcitonin gene-related peptide receptor antagonists) is continuing. Last year, Allergan gained the rights to two such medications from Merck – MK-1602 and MK-8031.

Merck ran into trouble several years ago with another one of it’s CGRP receptor antagonists, called MK-0974 and later Telcagepant, because of concerns about liver toxicity.

The two other drugs, however, belong to a different “chemical series”, and so far there has been no evidence of liver problems with these.

Farthest along is MK-1602, also known as ubrogepant. Ubrogepant is just about to enter phase 3 trials.

Back in June, ubrogepant was featured at a meeting of the American Headache Society. The report posted online said:

Researchers at Montefiore Medical Center and Albert Einstein College of Medicine conducted a randomized, placebo controlled, double-blind trial of the efficacy of ubrogepant in treating a single migraine attack. Patients who received the study medication reported a reduction in headache severity from severe or moderate to mild or none within two hours. Ubrogepant is free of known cardiovascular risk and may provide an important treatment option for individuals who suffer from cardiovascular disease. This trial supports ubrogepant’s effectiveness and provides further evidence that CGRP receptor antagonists are viable options for the acute treatment of migraine.

In other words, ubrogepant is another hopeful in the world of CGRP drugs for migraine.

Allergan is about to begin trials and will be looking for adults with episodic migraine who are interested in participating. At time of writing they are not yet recruiting participants. However, if you’re interested and want more information, visit the clinical trials page here: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

5 September 2011

Telcagepant Finally Shelved

James Medications, News 0

Telcagepant was a promising drug for migraine patients, with possibilities as both an abortive and a preventative. But in July, drug company Merck finally ended the clinical trials with no plans to recontinue them. Merck announced:

Merck is discontinuing the clinical development program for telcagepant, the company’s investigational calcitonin gene-related peptide receptor antagonist for the treatment of acute migraine. The decision is based on an assessment of data across the clinical program, including findings from a recently completed six-month Phase III study.

The drug (formerly known as MK-0974) was once a much talked-about drug with a promising future, as the leader of a new kind of migraine drug. Then researchers became concerned when some patients developed high levels of liver enzymes (transaminases).

The trials forged ahead in hopes that telcagepant would work better as an abortive. But Merck finally gave up trials. It had already shelved MK-3207, its other (CGRP) receptor antagonist for migraine.

This may be the end of telcagepant – but it’s by no means the end of this class of migraine medications. Researchers are pushing ahead with this and other types of medication that may fight migraine in the future.

But this is another reminder about the time and expense that’s put into developing new drugs. Though we have almost endless options today, we do pay for those options, and there’s a reason why.

22 September 2010

Telcagepant to be Sublingual

James Medications, News 1

On Monday the announcement came from Global Health Ventures, Inc., that they would be developing a sublingual version of migraine drug telcagepant.

Telcagepant, a calcitonin gene-related peptide receptor antagonist, has had a rocky beginning. Hailed in 2008 as the beginning of a new era in migraine treatment, the trials faltered over concerns about preventative use. Researchers were concerned when some patients developed high levels of liver enzymes (transaminases).

The drug’s developer, Merck, was cautious about the continued development of the drug, even as an abortive. Then, earlier this year, they announced that they would continue safety trials.

This past Monday, Global Health Ventures in Vancouver Canada, expressed their confidence in the future of telcagepant by announcing their commitment to developing a sublingual version. A special type of sublingual technology is one of the specialties of the company.

Global Health Ventures Inc. (the “Company”), a Specialty Pharma with focus on sublingual drug delivery, is pleased to announce that, it has initiated the development of a sublingual formulation of Telcagepant. Telcagepant is believed to be a powerful anti-migraine drug developed by Merck & Company. The drug blocks the recently discovered clacitonin-gene related hormone receptor (CGRP), a powerful vasodilator protein believed to be a key player in migraine.
…read more

30 April 2010

New Telcagepant Trial To Start This Year

James News 0

Drug company Merck is planning to start a new trial for the drug Telcagepant this year, a spokeswoman for the company says.

We last talked about this up-and-coming migraine drug back in October (see New Migraine Drug Telcagepant â€“ Not Dead Yet. It shows promise, but Merck stopped trials of Telcagepant as a preventative when some patients showed elevated levels of liver enzymes (read more here).

Merck took some time to discuss options with FDA (USA) officials. After some months, they have decided to go ahead with another safety trial in 2010, though they’re still working to design the study.

Telcagepant is one of a group of drugs called CGRP receptor antagonists. Many patients who haven’t benefited from triptan type drugs are looking forward to trying Telcagepant. However, researchers are also interested to see how Telcagepant and other CGRP receptor antagonists will work along with triptans.

Stay tuned to find out more about this upcoming study, and the results. Also, we hope to see other drugs in this class researched for migraine.

via Migraine Patients to Wait for Triptan Alternative

13 October 2009

New Migraine Drug Telcagepant – Not Dead Yet

James Discoveries & Stats, Medications, News 4

The pharmaceutical company Merck & Co., Inc was at the 14th International Headache Congress in September, talking again about the migraine drug Telcagepant. And hopes that Telcagepant will see the light of day aren’t dead yet.

After concerns about using Telcagepant as a migraine preventative, Merck has moved ahead with trials using the new drug as an abortive. Researchers were originally concerned when some patients developed high levels of liver enzymes (transaminases). (more on the background of Telcagepant here)

In one of the new trials, none of the patients had high levels of liver enzymes apparently caused by the drug (you caught that, right? Some did have the problem, but investigators felt it was not drug related.).

Two trials were reported on. First, compared with rizatriptan (Maxalt, Rizaliv, Rizalt), how many "adverse events" would patients experience?

Investigators didn’t look for any side effect here, they only measured events from a predetermined list. The adverse events were not too serious with either group, and there tended to be fewer with Telcagepant.

The problems more common with Telcagepant included nasopharyngitis, upper abdominal pain, and nausea and vomiting. In the other study, patients on telcagepant were more likely to feel sleepy (than those on a placebo). In an earlier study, Telcagepant was less likely to cause nausea than zolmitriptan, so we’ll see how it continues to compare with the triptans on this one.

But did Telcagepant fight symptoms of migraine? Yes, the results still look positive. In a large trial of 1,677 patients, researchers used doses of 140mg or 280mg and measured symptoms after 2 hours. They were interested in pain freedom or pain relief (reduction to mild or none). These charts show the percentage of patients helped at either dose, compared to a placebo:

Merck is preparing to have some major discussions regarding Telcagepant later this year with regulatory agencies. It remains to be seen if this drug will be the next big one for Merck and migraine, though it’s still showing promise.

The bad news is that Merck has shelved MK-3207, it’s other possible oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine treatment. So research on this type of drug continues to be stop and go for Merck.

However, Dr. David Michelson, vice president of clinical neurosciences, said Merck is still committed to this type of research: "Merck believes that the blocking of CGRP receptors remains an exciting pathway to address the underlying pathophysiology of migraine. We are continuing our efforts to offer patients a new treatment approach."

via: Merck Updates Status of Clinical Development Programs for Investigational CGRP Receptor Antagonist Treatments for Acute Migraine; MK-3207 Clinical Development Discontinued