Reduce the Frequency of Vertigo Attacks with a Dexamethasone Steroid Injection

Almost six months ago I had an injection that gave me my quality of life back. For weeks prior to the injection I went through a really bad patch of debilitating, daily mild Meniere attacks (two to three every other day). I was struggling to walk around the house, prepare food or even watch television without an attack coming over me. I was trapped.

Having been diagnosed with Meniere’s Disease almost four years earlier I had become accustomed to the occasional, acute vertigo attack lasting four to six hours, then having some periods of remission. Now that my hearing had eroded to moderate levels across all frequencies in my left ear, Menieres had taken on a new form. The frequency of the mild attacks was so debilitating that I longed for the days of the acute four hour attack even with the vomiting. At least I knew those attacks would eventually end and I could get back to my life within days. Now the mild attacks were so consistent that could barely feed myself or shower without feeling that another attack was imminent. I was broken and I couldn’t see an end to this new reality.

I’m not generally a prayerful person but I remember in desperation saying out loud one night, “If I have any guides out there, please help me. I need your help.” Angels, guides, spirits, whatever… I needed some divine intervention. I then Googled “Meniere” in the news section, as I did weekly, and to my amazement a pharmacology press release had been uploaded just one hour earlier (see link below). It was about clinical findings for a slow release steroid called “OTO-104” that was a type of Dexamethasone. Well I’d never heard of Dexamethasone. I’d never read anything about it in the Meniere’s Australia member’s literature or on internet forums. So I Googled Dexamethasone and found out that it had been around for years. Some people in the forums had heard of it, but very few had tried it. One person who had tried it said it was the most painful thing he had ever experienced. Okay then… it’s still more appealing than daily Ménière attacks.

I had heard of Gentamicin injections and to be honest, they sound frightening. Not the injection itself, but the fact that it annihilates the hearing & balance in the treated ear. It seems very extreme to me. Like killing a fly with a sledgehammer. Dexamethasone shouldn’t damage your hearing or balance system. Gentamicin definitely will.

Even though OTO-104 was not available, I knew I had to try Dexamethasone as soon as possible because I was loosing my independence and quality of life to Menieres. So I rang up my regular ENT in Brisbane who has over forty years experience and asked if he had ever administered a Dexamethasone intratympanic injection for Menieres. His receptionist asked the ENT and to my surprise he had not. Gentamicin yes, Dexamethasone no.

So I rang up another ENT that I had been to before whose special interest is Otology; Dr Chris Que-Hee in Wickham Tce, Brisbane. His receptionist said that he had administered a few of these injections before. Good enough for me. I booked in immediately.

THE PROCEDURE

The day of the injection was rainy, and as we Meniere sufferers know, rain can exacerbate Meniere symptoms, so I took twice the Natrilix SR (Indapamide Hemihydrate 1.5mg) than I would normally (therefore 3mg). I wasn’t asked to do this but I wanted to keep my system as dry as possible on this rainy, injection day. Also as a precaution about 40 minutes before the injection I took 1mg Valium (half a 2mg diazepam tablet) and a Stemzine tablet (prochlorperazine maleate 5mg) to minimise feeling sick during the procedure.

Before the procedure Dr Que-Hee discussed the pros and cons with me so I felt comfortable to proceed. We went into the procedure room and I sat in the patient’s reclining chair. The room was a little cool and a light weight blanket would have been nice (if only for the psychological benefits of feeling nurtured during this potentially stressful procedure).

Dr Que-Hee put a numbing agent on the eardrum of the ear to be treated. It felt cool and a bit uncomfortable for about 30 seconds. We waited a few minutes, then he made a small incision on my ear drum. I heard a small “pop” but it wasn't painful. He then inserted a small Myringotomy tube into the eardrum. So far so good. I was coping well. He then informed me that he would be injecting the Dexamethasone steroid. I was ready for the “excruciating pain”. Bring it on.

At times like this I try to clear my mind and focus my attention on my “happy place”. For me, that is visualising that I’m lying on a beach. I can feel the warmth of the sand under my back, hear the sound of the waves crashing gently on the shore, and feel the cool breeze rustling through the palm fronds above. You get the idea.

So the moment of truth arrives. The doctor injects the Dexamethasone through the myringotomy tube into my middle ear, aiming the solution at the “round window” which lies between the middle ear and the inner ear. If done correctly, much of the steroid solution will be absorbed through the “round window” and into the inner ear, directly targeting the location of the Ménière’s disease (see image above).

As the 40mg of Dexamethasone is gently injected I feel the cool, room temperature solution permeate my warm middle ear. I start to feel the mild spinning and the nystagmus begin. I think I briefly swore as I tried to stay focused on my “happy place”. I’ll be honest, it wasn’t pleasant… but it wasn’t painful. I just lay there and pushed through the discomfort, knowing that I had everything to gain from this momentary uneasiness. I closed my eyes and after a short time the steroid solution warmed up and the spinning stopped.

I then had to turn my treated ear skyward and lie on my good side. Dr Que-Hee put an alarm near my head and asked me to lay in that position for 25mins. I was in no pain but I did notice a dull ache. It certainly wasn’t the excruciating pain I had read about on a forum. That said I’ve been told in the past that I have a high threshold for pain. A man might have shed a tear, but not me. Go to your “happy place” and just push through.

After the 25mins I sat up and didn’t feel off balance. Dr Que-Hee told me that it should take effect within a few days.

As I was driven home I chose to keep my head tilted to get the best results so that the solution could permeate the inner ear. When I got home I lay on my good side for a further 30mins just to be thorough.

THE RECOVERY

Over the following two days I definitely noticed the good ear felt calmer. The tinnitus seemed to subside substantially. It would make sense that if Ménière’s Disease is an autoimmune disease that a steroid like Dexamethasone injected directly to the site of the disease would make a positive impact. Unlike taking a course of Prednisone tablets as I have in the past, a Dexamethasone injection in the middle ear is not going to affect your overall body the same way. Over use of Prednisone can lead to dangerous complications such as Cushing's Syndrome. By all means try Prednisone. I had some good results with it, however as a person with moderate hearing lose in my damaged ear and after four years since diagnosis, I believed Dexamethasone to be a good option for me.

The procedure cost me a few hundred dollars (AUD) much of which was claimable on my private health care. I recall some of the cost was rebated by Medicare (Australian public healthcare). 

The treated ear needed to be kept dry until the incision in the ear drum healed, which took 3 to 4 weeks. Until then I used ear putty & a shower cap from the chemist to keep the ear drum dry. 
 

IN SUMMARY

If you find yourself in a position like I was, experiencing multiple attacks every other day and daily life has become unmanageable, I highly recommend that you book in with an ENT, Otologist or Neurotologist/ Otoneurotologist and discuss having a Dexamethasone intratympanic injection. Now six months later, I’m happy to report that although I’m not Ménière’s free or “cured”, I’m no longer a dependant invalid. I’ve had only four or five mild attacks in six months; a significant improvement that’s well worth the momentary discomfort. Go to your “happy place”.

HAVE YOU OR SOMEONE YOU KNOW HAD A DEXAMETHASONE INTRATYMPANIC INJECTION?
IF SO, TELL OTHERS ABOUT IT BY LEAVING A COMMENT BELOW.
Read my follow up post More on Intratympanic Dexamethasone Injections

Otonomy Presents Positive New Findings from Phase 1b Study of OTO-104 in Ménière’s Disease at International Conference

Otonomy Presents Positive New Findings from Phase 1b Study of OTO-104

Observed Clinical Activity Suggests OTO-104 Provides Clinically Meaningful Reduction in Vertigo Frequency and Improvement in Tinnitus

San Diego, CA, September 29, 2011 -- Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company’s lead product candidate, OTO-104, in patients with Ménière’s disease. The presented data showed that patients treated with OTO-104 experienced clinically meaningful reductions in vertigo frequency and improvements in tinnitus as compared to placebo. These results were presented today in an oral presentation at the 28th Politzer Society Meeting in Athens, Greece.

Researchers presented findings showing clinically meaningful reductions in vertigo frequency at three months with the 12 mg OTO-104 dose as compared to placebo. Prior to treatment, patients in both the 12 mg OTO-104 and placebo groups experienced an average of eight days with definitive vertigo episodes during a baseline period of one month. Following a single intratympanic (IT) injection, patients in the 12 mg OTO-104 group experienced a month-over-month reduction in vertigo frequency throughout the three month follow-up period, and achieved an approximate six day reduction in the number of definitive vertigo days in the third month versus baseline. When compared to placebo, at three months following treatment, the 12 mg study group experienced a 70 percent greater reduction from baseline in the number of days with definitive vertigo episodes. There was no clinically meaningful difference in vertigo frequency between the 3 mg OTO-104 and placebo groups at three months following treatment.

Additionally, the presented study data demonstrated that both the 3 mg and 12 mg OTO-104 doses were associated with improvement in tinnitus as measured by the Tinnitus Handicap Inventory (THI-25). THI is a clinically validated patient-reported measure that can be used to quantify the impact of tinnitus on activities of daily living. Both OTO-104 doses resulted in reductions in THI Total Score from baseline as early as one month following treatment. Furthermore, these THI Total Scores continued to decrease throughout the entire three month follow-up period, suggesting continued improvement in tinnitus symptoms experienced by patients treated with OTO-104. By contrast, the study’s placebo group demonstrated little change in THI Total Score from baseline during the three month follow-up period.

As previously reported, results from this study showed OTO-104 to be safe and well-tolerated at both doses tested when delivered via a single IT injection. It is important to note that despite demonstrating meaningful clinical activity in the areas of vertigo and tinnitus, this study was not powered to demonstrate statistical significance. Based on these study results, Otonomy will initiate a Phase 2 clinical trial of OTO-104 in Ménière’s disease during the fourth quarter of 2011.

“These new results provide the first demonstration of OTO-104’s clinical activity in a cohort of Ménière’s disease patients experiencing frequent vertigo episodes,” stated Paul R. Lambert, M.D., professor and chair of the department of otolaryngology – head and neck surgery, Medical University of South Carolina, and the study’s lead investigator. “Furthermore, the continued reduction in vertigo frequency and improvement in tinnitus symptoms for the 12 mg OTO-104 group observed through three months of follow-up provides a strong rationale for initiating broader clinical evaluations of this sustained release product.”

A total of 44 patients with unilateral Ménière’s disease were enrolled in this prospective, randomized, double-blind, placebo-controlled multicenter study. Patients participated in a one-month baseline period to characterize disease status, followed by randomization to receive a single IT injection of OTO-104 (3 mg or 12 mg) or placebo. Patients were monitored over a three-month observation period following injection. The study’s primary objective was the evaluation of the safety and tolerability of OTO-104. Additionally, the study evaluated various indicators of OTO-104 clinical activity including changes in vertigo, tinnitus, hearing function and patient quality of life.

“Following a meeting with the United States Food and Drug Administration regarding these Phase 1b results and our proposed plans for continued clinical development of OTO-104, we are now in a strong position to move this program forward,” said David A. Weber, Ph.D., president and chief executive officer of Otonomy. “Importantly, our upcoming Phase 2 study will include a much greater number of patients and be powered to deliver statistically significant findings with regard to clinical efficacy. As such, we look forward to the initiation of this study as we seek to establish the therapeutic potential of OTO-104 to help patients suffering from the debilitating symptoms of Ménière’s disease.”

About OTO-104

OTO-104 is a sustained release formulation of the steroid dexamethasone that has been designed for intratympanic (IT) injection into the middle ear for the potential treatment of a broad range of inner ear disorders including vertigo, hearing loss and tinnitus. OTO-104 is based on Otonomy’s proprietary formulation technology which is intended to overcome the limitations associated with the use of unapproved short acting solutions in the ear. These include limited drug exposure, large variability of delivered dose and the need for multiple IT injections.

About Ménière's Disease

Ménière's disease is a disorder of the inner ear characterized by acute episodes of vertigo, fluctuations in hearing, tinnitus and aural fullness. The underlying cause of Ménière's disease is unknown and there are currently no FDA-approved drug treatments. According to the National

Institute on Deafness and Other Communication Disorders (NIDCD), approximately 615,000 individuals have been diagnosed with Ménière's disease in the United States.

About Otonomy

Otonomy is a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear. There are currently no FDA-approved drug treatments for the nearly 30 million Americans that are affected by debilitating hearing and balance diseases and disorders such as Ménière's disease, sudden sensorineural hearing loss, noise-induced hearing loss, age-related hearing impairment and tinnitus. Otonomy’s core technology is a sustained release formulation developed for optimal delivery of drugs to the middle and inner ear with a single IT injection. This technology has broad applicability across a range of therapeutic classes and two products based on this platform are in active development.

Otonomy's lead product candidate, OTO-104, is a sustained release formulation of the steroid dexamethasone. The company has finalized plans for a Phase 2 clinical trial in Ménière’s disease patients and plans to initiate the study during the fourth quarter of 2011. Additional future studies of OTO-104 are being planned in other inner ear disorders. OTO-201, the company’s second product candidate, is a novel sustained release antibiotic being developed in the field of otitis media. OTO-201 clinical trials are expected to begin in 2011. Additional product candidates are expected to target acute and chronic forms of hearing loss, balance disorders, and tinnitus.

For more information visit: www.otonomy.com.

 

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