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Senior Scholar, Johns Hopkins Center for Health Security, Baltimore, Maryland

A 68-year-old man presented with two growths on his chest, which he said had been slowly expanding over the past 2 years. They were occasionally tender and had bled with minimal trauma.

Can you identify the 2 slowly expanding growths on the chest of this 68-year-old man?

Clinical Topics

Pearly Pink Chest Lesions 

The US Food and Drug Administration (FDA) has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya; Tonix Pharmaceuticals) for the treatment of fibromyalgia in adults, marking the first new therapy for the condition in more than 15 years, according to a company news release.

“The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes,” said Seth Lederman, MD, chief executive officer of Tonix Pharmaceuticals, in the news release. “At Tonix, we recognized the transformative potential of pursuing a new approach with Tonmya for fibromyalgia, a chronic overlapping pain condition that has gone without innovation for many years.”

, is a first-in-class, non-opioid, once-nightly analgesic formulated for sublingual administration, designed for rapid absorption and reduced production of the long half-life metabolite norcyclobenzaprine. According to Tonix, the drug’s mechanism targets nonrestorative sleep, a core feature of fibromyalgia, with potential to improve associated pain and functional impairment.

The approval was supported by efficacy data from 2 pivotal phase 3 randomized, double-blind, placebo-controlled trials (RELIEF and RESILIENT), which enrolled nearly 1000 adults with fibromyalgia. In both studies, participants receiving Tonmya experienced significantly greater reductions in daily pain intensity scores over 14 weeks compared with placebo. A higher proportion of patients in the active-treatment group also achieved at least a 30% improvement in pain.

“For many years, rheumatologists like myself and other healthcare professionals have had to manage fibromyalgia with limited options that do not adequately meet treatment needs for the majority of patients,” said Philip Mease, MD, director of rheumatology research at the Providence Swedish Medical Center and clinical professor at the University of Washington School of Medicine, in the news release. “Tonmya is a novel treatment approach that targets nonrestorative sleep that is characteristic of fibromyalgia and can impact core symptoms, specifically pain.”

Safety findings across 3 phase 3 trials (n >1400) indicated that Tonmya was generally well tolerated. The most common adverse events (incidence ≥2% and higher than placebo) included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

How will this approval impact the fibromyalgia patient population?

Fibromyalgia affects an estimated 10 million US adults, approximately 80% of whom are women. The disorder is characterized by chronic widespread pain, fatigue, nonrestorative sleep, cognitive dysfunction, and mood disturbances, and is associated with significant reductions in quality of life and increased healthcare utilization.

“I know firsthand how the chronic pain of fibromyalgia significantly disrupts my patients’ lives,” said Andrea L. Chadwick, MD, MSc, FASA, anesthesiology, pain, and perioperative medicine at The University of Kansas Health System. “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time. Tonmya is administered sublingually which is designed to reduce pain quickly and durably with a tolerable safety profile.”

Sharon Waldrop, founder of the Fibromyalgia Association and a person with lived experience with fibromyalgia said this is a major milestone for patients.

"For over 15 years, this community has been underserved and waiting for new treatment options. This approval is a promising step forward and brings renewed hope to millions.”

When will Tonmya be available in the U.S.?

Tonmya is expected to be commercially available in the United States in the fourth quarter of 2025.

Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals announces FDA approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia [news release]. GlobeNewswire. August 15, 2025. Accessed August 15, 2025. https://ir.tonixpharma.com/news-releases/news-release-details/tonix-pharmaceuticals-announces-fda-approval-tonmyatm

The US FDA approved Tonmya, a groundbreaking treatment for fibromyalgia, offering hope to millions experiencing chronic pain and sleep issues.

FDA News

New Fibromyalgia Treatment: FDA Approves Once-Daily Nonopioid Analgesic TNX-102 SL

The American College of Cardiology (ACC) emphasizes that vaccine hesitancy is a distinct and important barrier to preventive care in patients with 

 Unlike vaccine resistance, which reflects firmly held opposition, 

 shaped by a range of influences—socioeconomic challenges, misinformation, social norms, prior vaccine experiences, and, at times, distrust of the health care system, the ACC states. 

 amplified these concerns, as rapidly evolving evidence and the urgency of new vaccine development fueled uncertainty.

on vaccination in adults with cardiovascular disease (CVD), underscoring the importance of 

—including influenza, COVID-19, and respiratory syncytial virus (RSV)—as part of standard prevention and treatment strategies. The augmented and lingering halo of uncertainty around immunization is particularly concerning as the US is about to enter the 2025-2026 respiratory virus season. 

The ACC’s new CCG emphasizes that addressing vaccine hesitancy starts with understanding its root causes and tailoring interventions accordingly. Education from a trusted clinician, particularly in routine care, is the most effective approach. Clear explanations of vaccine benefits, expected side effects, and common misconceptions—such as the belief that influenza vaccination can cause influenza—help reduce uncertainty. In a dedicated section of the CCG, the ACC presents a number of the questions most frequently asked by adults with heart disease who are vaccine candidates, eg, about infection risk, vaccine safety, myocarditis, cost, and the need for repeated doses. All reflect concerns that fuel hesitancy. 

In the short slide show above, we present the ACC's FAQs and several others based on the CCG, and the ACC's suggested departure point for an answer. Overall, the ACC sends a clear message: vaccine hesitancy is not immovable, and clinicians have a central role in guiding patients through uncertainty toward informed decisions.

How to Address Barriers to Immunization for Adults with Cardiovascular Disease

2025 Concise Clinical Guidance: An ACC Expert Consensus Statement on Adult Immunizations as Part of Cardiovascular Care. 

Based on the FAQ section in the ACC's 2025 Concise Clinical Guidance on vaccination in adults with CVD, this short slideshow also offers recommended answers. 

Toolkits

8 FAQs About Vaccination From Patients With Cardiovascular Disease 

A 64-year-old woman with a history of basal cell carcinoma presents to the dermatologist for skin cancer surveillance. She is incidentally noted to have bruising on her upper eyelids (above). On questioning, she reports experiencing recurrent intermittent eyelid bruising for several years. She denies a history of trauma to her face, pain, or other associated symptoms.

Her medical history is significant for hyperlipidemia, hepatitis C (diagnosed >30 years earlier), osteoporosis, celiac disease, and idiopathic proteinuria for several years. Her surgical history includes appendectomy and carpal tunnel repair.

Pertinent family history includes her mother dying of multiple myeloma and her father of complications of diabetes.

Review of systems is significant for vague symptoms of gastrointestinal discomfort. On more directed questioning, she reports the eyelid purpura is temporally related to the Valsalva maneuver/ strained bowel movements. Her medications include atorvastatin, risedronate sodium, a daily multivitamin, calcium, vitamin D, and aspirin.

Her examination reveals no bruising elsewhere and no findings of interest on skin or mucous membranes.

B. Allergic contact dermatitis, purpuric type

Eyelid bruising was observed on a 64-year-old woman during routine skin cancer follow-up. She denied trauma or pain. What does this look like to you? 

Image IQ

Image IQ: Recurrent Eyelid Purpura 

A 13 y/o boy is seen for a pruritic rash that been spreading x1 week; lesions are widespread over chest and back w axilla involvement. Recent hx of viral illness now resolved. PMH: noncontributory.

VIDEO: The lesions appear oval with trailing edge scale. Note the the pattern and distribution in the video interview; what's your diagnosis? 

Teen Boy with a Progressive Pruritic Rash 

No labs, no biopsies . . .  you can make this Doorway Diagnosis just by looking.

Pictured is the posterior right knee of a 69-year-old woman showing a rounded protuberance at the popliteal fossa.

No labs, no biopsies, no imaging -- only your seasoned clinical judgement is required to make a diagnosis in this case. 

Amesh Adalja, MD

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