Have you been hearing the buzz about the new medication approved for the treatment of fibromyalgia?
Fibromyalgia can come with a myriad of symptoms that make everyday life more difficult. With the limited pharmaceutical options available, the addition of another FDA-approved medication is a ray of hope. Tonmya™ is the first medication approved for fibromyalgia in over 15 years, promising a new option for those of us with fibromyalgia.
Today, Tami is joined by Dr. Seth Lederman, one of the co-founders of the company that developed Tonmya™, to talk about the journey from idea to FDA approval and what it could mean for the fibromyalgia community. With decades of experience in rheumatology, immunology, and drug development, Dr. Lederman has been focused on helping people with fibromyalgia for much of his career.
In this conversation, Tami and Dr. Lederman discuss his medical and research background, why he focused on fibromyalgia, advances in fibromyalgia research, the FDA approval process, why Tonmya™ targets non-restorative sleep and Dr. Harvey Moldofsky's influence, clinical trial design, dosing studies, and FDA requirements, outcomes measured in trials and the focus on pain reduction and sleep challenges, challenges in developing Tonmya™ including high placebo response and financial risks, how Tonmya™ differs from Flexeril, side effects of Tonmya™ and how it compares to other treatments, how quickly patients may see benefits, tolerability and safety considerations, when Tonmya™ will be available and how it will be distributed, how patients can access Tonmya™ and find more information, efforts to make Tonmya™ affordable, the need for advocacy and raising awareness, future steps for Tonmya™, what you need to know about the criticisms of early Tonmya™ studies, and more.
Note: This episode is not meant to be medical advice. Every person and every situation is unique. The information you learn in this episode should be shared and discussed with your own healthcare providers.
To learn more about the resources mentioned in this episode, visit the show notes.
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