VERTIGO-OTO-104 'miracle drug' hope as patients notice instant improvement

http://www.mirror.co.uk/news/uk-news/vertigo-sufferers-offered-oto-104-6891352

Victims of the debilitating disease that affects one in 2,000 people could benefit from a new drug after successful trials.
61-year-old vertigo sufferer who spent up to seven hours a day vomiting, unable to even lift his head, has been symptom free for 200 days after undergoing pioneering treatment.

Father-of-one Colin Breeze underwent a series of injections into his inner ear with a new steroid drug called OTO-104.

He said: "From the first injection I noticed improvements.

"I still had three attacks in the three months but that reduced it from one attack a week to one a month.

"From May, when I had my second injection, I have never looked back. There was an immediate improvement and now I'm able to enjoy life again."

Colin suffers from Meniere's disease, which occurs in around one in 2,000 people in the UK and affects the inner ear.

Famous sufferers include BBC Springwatch presenter Chris Packham.
It causes vertigo, dizziness and sufferers can also experience tinnitus, hearing loss, and a feeling of pressure deep inside the ear.
Doctors don't know what causes the disease and until this breakthrough were unable to effectively treat it.

Colin suffered from tinnitus, also known as ringing in the ear, for two years before he developed Meniere's and contacted his GP as his symptoms started to deteriorate 15 months ago.

The doctor told him he had the condition and said there was little he could do as no cure existed.

As the condition progressively worsened, the once active customer service manager and his wife Christine were left in despair.

Then November last year Colin met consultant ENT surgeon John Phillips, who was testing OTO-104 at the Norfolk and Norwich University Hospital.

He invited him to take part in the experiment where recipients' inner ears were injected with a thick steroid substance that slowly dissolves over a period of months, helping alleviate the disease's symptoms.

As the drug is still in its trial stage it is not known whether this will permanently cure the disease.

Colin, from King's Lynn, Norfolk, had his first injection in February and one every three months until September.

The trial has now finished and Colin will go back for a check-up next year when he is hoping to be told the disease has gone for good.

He said: "I cannot tell you how grateful I am that I got this drug because my life was going nowhere. At one point I was having attacks every week.
"Each attack lasted between three and seven hours and I couldn't even lift my head.

"If you'd said to me here's a million pounds, get yourself up those stairs or even onto the settee, I couldn't have done it, it was absolutely impossible.

"It's the most debilitating thing I've ever experienced in my life, the feeling was horrendous.

"After each attack I was exhausted and had to have two to three days off work to recuperate.

"I thought this is it, I'm going to lose my job and life. I'd adjusted myself to accept that the rest of my life was going to be a misery."

Mr Phillips said most of the 18 people on the same trial as Colin at the hospital have responded well to the treatment, and he was by no means the exception.

He added: "We can't really say it's a miracle cure at the moment because we haven't finished the stage three of the trial so we do not know if Colin's recovery was just by chance or whether it was down to the drug but the results are very encouraging."

Mr Phillips revealed that in another trial carried out in America by the drug's developer, Otonomy, it was shown to help majority of sufferers when compared with people given a placebo.

A much larger study will be launched in the US, UK and parts of Europe next year to see its effectiveness.

Colin said: "I can't speak highly enough of the doctors and nurses. It had turned my life around.

"The disease made my life a misery and I hope that now other sufferers will be able to get access to this drug and not have to endure this horrible disease any more."

Since being 'cured' Colin has been able to spend more time working on restoring his beloved classic cars and supporting his racing driver son Carl, 35.

The disease is named after French physician Prosper Meniere's, who wrote a paper about it in 1861.

Meniere's sufferers are estimated to make up around 10 per cent of people who suffer from vertigo.

It has not yet been tested on people who suffer dizziness.

The hospital was wary of calling the drug a cure but are hopeful that future studies will establish whether it is effective.

 

good info gardengal thanks.

 

http://www.otonomy.com/pipeline/oto-104/
Clinical Trials

OTO-104


OTO-104 is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of patients with Ménière’s disease.

Ménière’s disease is a chronic condition characterized by acute vertigo attacks, tinnitus, fluctuating hearing loss and a feeling of aural fullness. Of these symptoms, the vertigo attacks are typically most troubling for patients since they disrupt daily activities and are difficult to anticipate and manage. In general, patients are diagnosed with unilateral Ménière’s disease in middle age and symptoms often continue for decades. Over time, the fluctuating hearing loss becomes permanent in many patients, and a subset of patients will develop symptoms in their second ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 patients diagnosed with Ménière’s disease in the United States. There is no known cure for Ménière’s disease and there are currently no FDA-approved drug treatments.

In May 2015, we announced results from a Phase 2b trial evaluating OTO-104 in 154 patients with unilateral Ménière’s disease. The primary endpoint of the trial was reduction in vertigo frequency during Month 3 following treatment compared to a one month baseline period. In the topline analysis, OTO-104 demonstrated a 61% reduction from baseline in vertigo frequency in Month 3 vs. 43% for placebo with a p value of 0.067, which narrowly missed achieving statistical significance. The trial achieved statistical significance (p < 0.05) for multiple prospectively defined secondary vertigo endpoints at multiple time points including the count of Definitive Vertigo Days (DVD) that achieved statistical significance in both Month 3 (p = 0.030) and Month 2 (p = 0.035). Based on these results, and discussions with the FDA during an End-of-Phase 2 meeting, we intend to conduct two parallel Phase 3 trials in Ménière’s disease using DVD during Month 3 as the primary endpoint. The first Phase 3 trial has recently been initiated in the United States and a second trial is expected to begin in the EU during the first quarter of 2016. Results of both Phase 3 trials are expected in the second half of 2017. Patients completing the Phase 3 trials will have the opportunity to enroll in an open label safety study and receive two quarterly doses of OTO-104.

In April 2015, we announced the completion of enrollment in a multiple-dose safety study of OTO-104 in patients with Ménière’s disease. This study is designed to evaluate the safety of quarterly dosing of OTO-104. The study enrolled a total of 128 Ménière’s patients across multiple trial sites in the United Kingdom (UK). We plan to initiate a small open label safety study of OTO-104 in Canada to supplement the number of patients treated for one year in the multiple-dose UK study.

OTO-104 for Ménière’s disease has been granted Fast Track designation by the FDA. We also plan to assess and prioritize additional opportunities for OTO-104 including other balance disorders, acute onset sensorineural hearing loss and tinnitus.

 

sorry to hear that hopefulstill but glad your vertigo isn't often enough, but more than 1 time is too often