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Ronny Allan
What is Telotristat Ethyl?
Telotristat Ethyl is a significant introduction to the treatment of Carcinoid Syndrome diarrhea. It’s the first addition to the standard of care in more than 16 years and the first time an oral syndrome treatment has been developed. The drug was previously known as Telotristat Etiprate but was changed to Ethyl in Oct 2016. ‘Etiprate’ was previously a truncation of ‘ethyl hippurate’. The brand name is XERMELO®
4th April 2022 update
SERB is pleased to announce it has acquired the rights from Ipsen to commercialize Xermelo® (telotristat ethyl) in Europe and other countries outside the US and Japan. Xermelo® will be commercially available from SERB outside the US and Japan starting in July 2022. The announcement appears to infer that SERB are working with BTG Specialty Pharmaceuticals to complete this task. (SERB acquired BTG in 2021). Both appear to be European based companies.
The drug owner, TerSera Therapeutics LLC, retains the rights within US and Japan.
24th March 2021 update
A new Phase 3 clinical trial entitled Telotristat Ethyl for the Treatment of Carcinoid Heart Disease in Patients With Metastatic Neuroendocrine Tumor. As usual, the inclusion and exclusion criteria should be carefully examined. Read more – click here.
1st Aug 2020 Transfer of Ownership
In a move that Lexicon Pharmaceuticals Inc. chief Lonnel Coats said will focus the company on its phase II neuropathic pain program, The Woodlands, Texas-based venture has agreed to sell one of its two approved products, the carcinoid syndrome diarrhea therapy Xermelo (telotristat ethyl), to TerSera Therapeutics LLC. I don’t expect this to make any difference to the drug or its supply. Business as usual. The outer package may change to reflect new owners but the brand name XERMELO will most likely be part of the sale.
Read the news from Lex Pharma – click here.
Who is the drug for?
The drug may be of benefit to those whose carcinoid syndrome diarrhea is not adequately controlled by somatostatin analogues (Octreotide/Lanreotide). It doesn’t replace somatostatin analogues – it is an additional treatment alongside.
Where is it currently approved?
The US FDA approved the drug 28 February 2017.
On 19 September 2017,the European Commission approved Xermelo® (telotristat ethyl) for the treatment of carcinoid syndrome diarrhea in patients inadequately controlled by somatostatin analogue therapy after the scientific committee of the EMA (known as Committee for Medicinal Products for Human Use (CHMP)) adopted a positive opinion recommending the approval of Xermelo® (telotristat ethyl) 250 mg three times a day for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analogue (SSA) therapy in adults inadequately controlled by SSA therapy. The Ipsen press release is here.
This does not mean all EU countries will use it. Clearly some action will be required in EU national countries before the drug becomes available through appropriate healthcare systems.
On 17 Oct 2018, Health Canada announced approval for NET patients – click here.
UK. 8th January 2020. NHS England did not approve Xermelo with the following statement:
“NHS England has carefully reviewed the evidence to treat CS diarrhoea with telotristat. We have concluded that there is not enough evidence to make the treatment available at this time”. NHS Scotland and Wales have authorised it for “Restricted use”. Restricted use means a narrow meaning to approval, perhaps a particular subset of patients who would benefit most. There is no data about Northern Ireland.
For all other countries please see the update above on 4th April 2022.
How does it work?
In the simplest of terms, the drug is an inhibitor of the enzyme tryptophan hydroxylase (TPH). TPH is the rate-limiting enzyme in serotonin synthesis which converts tryptophan (an essential amino acid which comes from diet) to 5-hydroxytryptophan, which is subsequently converted to serotonin, one of the main causes of carcinoid syndrome effects including carcinoid heart disease. The trial data indicates that Telotristat ethyl significantly reduced the frequency of bowel movements. Furthermore, it was also associated with “significantly reduced levels of urinary 5-HIAA“, a marker for systemic serotonin levels, which are typically elevated in severe carcinoid syndrome and carcinoid heart disease. Essentially it works by reducing the manufacture of Serotonin so it may not have any effect on diarrhea not caused by syndrome (i.e. post-surgery etc).
For US patients only. Did you know the manufacturer had a Nurse Specialist Helpline?
Questions about XERMELO? Get the answers you need from a Carcinoid Syndrome diarrhea expert
Talk to a Clinical Nurse Educator (CNE) for the right support each step of the way. These CNEs have years of experience with Carcinoid Syndrome diarrhea and are dedicated to supporting you.
- Make XERMELO part of your routine and stay on track with treatment
- Easily identify Carcinoid Syndrome-friendly foods (you’ll receive a FREE Nutrition Guide, too)
- Learn about the role of hormones, including serotonin, in NETs
- Set up convenient text reminders to take your medication 3 times a day (optional)
Note: The CNEs can share general information about NETs and Carcinoid Syndrome but cannot provide medical advice on your specific condition.
Meet the CNEs here. They can help you.
March 2018 update
The March 2018 issue of Clinical Therapeutics provides the first report of the effects of XERMELO on changes in weight in patients with neuroendocrine tumors (NETs) and carcinoid syndrome that participated in the TELESTAR study. You have to remember that XERMELO is approved for those with carcinoid syndrome diarrhea not adequately controlled by somatostatin analogues (author’s note – i.e not for diarrhea caused by (say) side effects of surgery).
Of the 120 patients with weight data available, up to 32.5% of patients treated with XERMELO experienced significant, dose-dependent weight gain (≥3% from baseline). Only 5.1% of patients on placebo experienced weight gain. Importantly, patients with weight gain experienced improvement in carcinoid syndrome control, as seen in reduction of bowel movement frequency and in parameters of nutritional status associated with positive changes in patient-reported outcomes compared with patients with stable weight or weight loss. Those patients also experienced reduced u5-HIAA levels. Patients with weight gain also experienced fewer serious adverse events than patients with stable weight or weight loss.
(see link below)
Resources for your perusal:
- You can read more about the trial data in a summary by Dr Matthew Kulke (Dana Farber) by CLICKING HERE (latest review from 2017 ASCO).
- There is also an excellent summary in video form by Dr Lowell Anthony (University of Kentucky) by CLICKING HERE. (“any reduction in diarrhea is meaningful“).
- The detailed output from the trial (results) can be found by CLICKING HERE.
- Great 2016 article from ASCO (American Society of Clinical Oncologists) can be found by CLICKING HERE.
- FDA Approval. CLICK HERE
- Lex Pharma press release on approval. CLICK HERE
- EU Approval (Ipsen Press Release). CLICK HERE
- The manufacturer Lex Pharma has established a dedicated site – CLICK HERE
- 2018 revised clinical data – CLICK HERE
Serotonin Video with myself and Dr Mike Morse
I made a video in 2019 with Dr Mike Morse sponsored by Lexicon Pharmaceuticals, Inc. It’s all about Carcinoid Syndrome with a slant towards hormones, in particular Serotonin Entitled “Likely Suspects: How Hormones May Lead to Carcinoid Syndrome – What People Living with Carcinoid Syndrome Need to Know”
You need to register to watch although some of you will already be registered and just need an email to login to see this webcast. Click on the link here: www.CarcinoidWebcast.com
Don’t forget to press the play button and ensure your sound is turned up, particularly on mobile devices.
Disclaimer
I am not a doctor or any form of medical professional, practitioner or counsellor. None of the information on my website, or linked to my website(s), or conveyed by me on any social media or presentation, should be interpreted as medical advice given or advised by me.
Neither should any post or comment made by a follower or member of my private group be assumed to be medical advice, even if that person is a healthcare professional.
Please also note that mention of a clinical service, trial/study or therapy does not constitute an endorsement of that service, trial/study or therapy by Ronny Allan, the information is provided for education and awareness purposes and/or related to Ronny Allan’s own patient experience. This element of the disclaimer includes any complementary medicine, non-prescription over the counter drugs and supplements such as vitamins and minerals.
General Clinical Trials Disclaimer
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact. If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net
The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan.
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i have net tumors, I want to kno hou I can buy this new medical treatment, It,s not availabel in the Netherlands yet so I want to tray to buy it in the States. I hope that someone can tel me! thanks
http://xermelo.com/ I don’t really know if that’s possible Mans. However, if you make contact with this site, you will get the best advice. Let me know what they say please, in case someone else asks.
Hi Ronny
I would like to ask if the drug is avaliable in the drug market or from where we can get it ?
This is awaiting both FDA and EMA approval, due early 2017 (Feb). Once approved, Ipsen has the contract to distribute it worldwide less USA and Japan.
Ronny, nice blog! Do you know if there have been observational side effects of reducing tumor growth, like is seen with SSA’s?
Good question. I don’t see how there can be as it’s not that type of drug. It works by reducing the manufacture of serotonin from tryptophan. I just scanned the trial data output (it’s the last link in the blog text) but nothing relevant. To be honest, if there was any evidence of an anti-tumor effect, the manufacturers would be all over that like a rash!
Parabens! Obrigada pelos esclarecimentos!!!
obrigado 😀
Good update Rosie, I suspect people will be interested.
I’ve been talking telotristat since July 2013. I cannot imagine my life without it, so I sure hope my insurance will cover it reasonably once it goes to market and is no longer free to me!! I take both Telotristat and somatostatin analogues. My symptom control isn’t as great has what Mary Edwards has posted hers is, but believe me it made a major improvement in my quality of life. As well as reducing diarrhea & flushing, it seems to have cleared up foggy brain, reduced anxiety and other symptoms that aren’t normally mentioned as syndrome symptoms. It helped me so much, that when I had a kidney stone that didn’t want to pass, I told my urologist I would risk kidney damage waiting on it before I’d let him do surgery and get me kicked out of the trial! (That was in the early stage of the trial during a period I couldn’t have surgery and stay in the trial.) If I have any side effect from the medication, it might be a sensitivity to heat that I had never had before. Of course, that could be age related, (as I’ve never been this old before!) or disease related, and not a side effect.
Ronny, Excellent blog, as always! I am one of the Telotristat clinical trial patients, been taking it since November 2014 – 17 months now. It has made a major difference in the quality of my life. I have very few bouts of diarrhea, maybe 2 or 3 per month versus 12 or more per day! Flushing disappeared. Heart remains healthy. I still get abdominal pain – no differences there. But the freedom to plan and live my life and not worry about where bathrooms are is such a blessing. I hope this drug gets through the FDA hurdles and the regulatory agencies of all other countries very fast so that all carcinoid syndrome patients can have access to it. And I hope the manufacture does not get greedy with the pricing and that all the drug insurance plans cover it adequately.
Hi Mary, Thank you so much for your post. Can you tell me the dosage you are on or is it a standard dosage for everyone???
As a clinical trial patient, I was taking twice the dosage that it has not been officially approved for use by patients in the USA. I had been taking 500 mg three times daily. Now will be taking 250 mg three times daily.
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Thanks for information!! This is a very good News. I think I will need it.
This is indeed good news! Thank you for keeping us informed, Ronny.
Ronny, keep up your fantastic work! You are my only reliable and comprehensive source of information, Thank you!
Thank you, I might use this quote in my personal marketing if you don’t mind?
Please do so, if you like. To understand the background: I am en expat in Spain, so it is very difficult to find a group to share. Your blog is a fantastic source of information and sharing. Thanks!
As you are aiming to understand a lot of medical information, this article may be interesting for you ( and us with a little help of easier language.)
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00817-X/abstract
Thank you. That particular article needs to be purchased but I think I have a very similar article from the RADIANT trial.