Promising Results for New Trigeminal Neuralgia Drug

Promising Results for New Trigeminal Neuralgia Drug

A British pharmaceutical company is reporting positive results from a Phase II study of a new drug in patients with trigeminal neuralgia (TGN), a rare and severe form of facial pain.

Convergence Pharmaceuticals said the drug – a sodium channel blocker known as CNV101480 – significantly reduced the severity of pain and the number of sudden attacks (paroxysms) in TGN patients. Pain severity decreased by 55% and the number of paroxysms decreased by an average of 60% when compared to a placebo.

bigstock- woman Checking-The-Label-486812“Having worked in the field of TGN for over 20 years and managed hundreds of patients with this severe facial pain it is wonderful news to find that there is potentially a new drug to add to our armory which not only is effective but is also so well tolerated,” said Professor Joanna M. Zakrzewska, an expert in the field of facial pain at University College London Hospitals NHS Foundation.

“This is the first time that we have a drug specifically being trialed in TGN rather than using a previously developed anti-epileptic drug.”

A total of 67 patients with TGN participated in the study. Following an initial 21-day treatment period with CNV1014802, patients who showed a reduction in the number and severity of paroxysms were then randomly assigned to a 28-day double-blind treatment period with either CNV1014802 or a placebo.

CNV1014802 was well tolerated with no serious adverse events. The full study will be published at the International Association for the Study of Pain’s (IASP) World Congress of Pain in Buenos Aires , Argentina in October 2014.

CNV1014802 received orphan-drug designation from the Food and Drug Administration in 2013. Convergence said it will use data from the Phase II study to design a pivotal clinical study to start in early 2015, with the goal of commercializing the drug “as soon as possible.”

There have been very few well-controlled, randomized, placebo-controlled studies in trigeminal neuralgia, and the majority of drugs have had other primary uses. Due to the severity of the pain, it is not always practical or ethical to conduct a traditional placebo-controlled study.

Trigeminal neuralgia is a severe facial pain condition. Current guidelines for treating TGN recommend sodium channel blockers — carbamazepine or oxcarbazepine — as the first line of treatment. However, the drugs often have severe side effects, especially cognitive ones, and often interact with other medications.

“This is the first well powered, randomized and placebo controlled clinical trial to demonstrate efficacy of a selective state dependent Nav1.7 inhibitor in a chronic pain indication. This follows years of intensive research and provides huge promise for a better standard of treatment for TGN in the future,” the company said in a statement.

TGN is a very severe form of facial pain that usually involves sudden and severe episodes of pain, usually on one side of the face, which can be provoked by a light touch or even a breeze. The pain follows one or more branches of the trigeminal nerve, which provides nerve sensation in the mouth, face and the front of the scalp. The severity of the pain and its unpredictability can lead to significant depression or even suicide.

TGN affects about 50,000 people in the U.S alone. The majority of TGN sufferers are over 50 years of age, although cases have been reported in young adults. TGN is more common in women than in men, and for most sufferers, the condition is progressive and worsens over time.

Authored by: Pat Anson, Editor

There are 37 comments for this article
  1. Anne Morris at 12:22 am

    This is the most wonderful news, I’m not in a very good place at the moment… Will we be able to get it in Australia?

  2. Frans at 1:59 pm

    I am very interested if the new drug brings relief for atypical odontalgia, a form of atypical facial pain. When is it available in the Netherlands?

  3. Rob at 12:09 am

    I want to try iT also.
    I have atypical facial pain.
    Rob (Netherlands)

  4. Susan B at 11:48 am

    I would try it too. The Tegretol gives me brain fog.

  5. Paul Daly at 5:44 am

    If they need any trial patients in US please contact me. Desperate. Running out of time. Thanks.

  6. Dawn Miller at 10:39 am

    Has this medication been tried on children with TGN? My daughter is a bi-lateral TGN sufferer since the age of 11 she is currently 15 years old.

  7. LaTaesha Parrish at 6:15 am

    I would love to try it, I hate current meds.

  8. Steve at 1:49 pm

    When will this drug be sold. I have had TN for 2 years now, its driving me crazy. I have a hard time eating. Hope this drug is available soon!

  9. amy at 3:21 pm

    With all medicine comes a side effect…im happy to hear about the medicine but really need more information..but good to know it’s out there

  10. ALETTE FORMAN at 12:29 am

    This is wonderful I am running out of choices, and just labeled for TN. 2015 is not so long if you have had pain forever. I will look for news on it

  11. Wendy at 6:10 pm

    For those of you interested in taking part in the testing, apparently these tests are well underway — which is good news in terms of getting the drug to market. For future testing, the place to look in the USA is clinicaltrials.gov — so if you are interested in participating in a clinical trial, check in there every so often and see what is available in your area.

    Also, please look into the Facial Pain Research Foundation at facingfacialpain.org as they are doing research seeking to find a cure for TN. Yes, a cure, not just a treatment. Wild, I know, but true. This group deserves our support and has a lot of information on their site, too.

    This drug is good news, and we need more good news. TN is a horrific disease.

  12. Linda at 3:01 pm

    I am so happy but how long will it take to make it available to us. I’ve had this for 30 years and all of the treatments have failed. There are no more emissions and the pain has spread to every branch. I hope this is really good news!

  13. ROBERT KRINKIE at 9:10 am

    WONDERFUL NEWS! THANK YOU ALL! ANYWAY I CAN HELP,LET ME KNOW.BOB

  14. miki at 1:08 am

    Has it been tested for atypical face pain?

  15. Patty Justice at 11:00 pm

    I as well have ATN. Any results for those who have pain all of the time?? This is great news nonetheless!

  16. Page Marlow at 10:03 pm

    I have suffered since my early 30’s. I am now 51. I have tried everything including surgery. I would love to be part of this trial. This news could give me a new life!

  17. Jennie at 7:24 pm

    Will gladly be a test subject for this! After 2 MVD’s & Gammaknife, I’ll try anything!

  18. Howard at 1:58 pm

    Has it been tested for Type 2 TN?

  19. Beverly Helder at 11:54 am

    This brings tears to my eyes. I would celebrate with a glass of wine but alcohol makes the medicine not work. Maybe I will just dance. Wonderful news.

  20. Myriam at 10:23 am

    Hope it will work.. My mom suffers since many years.. It’s a killing pain

  21. Arie at 10:00 am

    This news is as uplifting as last Friday’s soccer match of the Netherlands against Spain. Unexpected successes taste best.

    With TGN we usually are in a world of declining opportunities.
    So good to have hopes for better future treatment options!

  22. Dolores r. Hale at 9:57 am

    More info such as side effects.

  23. Melinda Czeschin at 8:31 am

    Freakin awesome!!!!! I cannot wait to try it!!!

  24. Ruth M Banciu at 7:42 am

    Best news in a long time!

  25. melissa at 7:24 am

    Here is to hoping that this works. I see how much my sister suffers every day and really hope for some relief for her. It really breaks my heart!!

  26. Alison at 7:24 am

    Hopefully it won’t knock you out like amitriptyline does.

  27. Martha Petersen at 7:20 am

    Thank you, thank you. I will cry and then celebrate. So much suffering with a glimmer of hope.

  28. Deborah Rendell at 6:52 am

    I wish I could have participated been 17 weeks of pain now! Please hurry up and get it on the market!!

  29. Demelza Walker at 2:53 am

    This sounds great. Amazing even for us TN sufferers. How do we find out more about studies and maybe participating in them?

  30. Melanie at 9:15 pm

    How do you get on a trial? Have ATN and breakthrough pain

  31. Jessica at 8:29 pm

    Hopefully future testing goes well 🙂

    This could bring a lot of relief to people in pain from trigeminal neuralgia!

  32. Jeff at 6:33 pm

    Is it available, need something to work.