Leading the way for those left behind in pain
At Tremeau, we focus on well-defined patient populations with high unmet medical needs. Our unique approach to acute and chronic pain in select conditions is rooted in the mechanism of action, documented efficacy in painful inflammatory conditions, and clinically differentiated profile of COX-2 selective NSAIDs.
Tremeau believes that the multiple, often industry-independent, scientific evaluations of the past 15 years strongly suggest a re-examination of the potential utility of rofecoxib and etoricoxib. This is especially true with indications in which a COX-2 selective NSAID may provide therapeutic advantages over other standards of care, such as opioids.
*The active ingredient in TRM-201 is rofecoxib, which was previously marketed as VIOXX®.
VIOXX is a registered trademark of Tremeau Pharmaceuticals, Inc.
Hemophilic arthropathy (HA) is a painful and debilitating joint disease that affects people with inheritable bleeding disorders. It is caused by recurrent intra-articular bleeding. HA is one of the most common complications encountered by patients with bleeding disorders, and is the largest cause of morbidity in patients with hemophilia. There are currently no FDA-approved medications indicated to treat this type of joint pain, and opioids are the most frequently used prescription treatment.
Migraine is typically a moderate or severe headache that can cause throbbing pain, usually on one side of the head. It is often accompanied by nausea, vomiting, and extreme sensitivity to light and sound.
NSAIDs are often used alone or in combination with other therapies for patients suffering from migraines. However, some people may avoid NSAIDs because of their inhibitory effect on platelet aggregation. Two examples include patients with von Willebrand Disease (VWD) and patients suffering from menstrual migraines.
VWD is a bleeding disorder in which the blood does not clot properly. It is the world’s most common bleeding disorder and affects up to 1% of the U.S. population, although mild cases are often undiagnosed. Evidence suggests that people with VWD are 4-10 times more likely to experience migraine than the general population.
Among female migraineurs, 60% suffer from menstrual migraines, and attacks are 2-3 times more likely to occur during menstruation. These attacks can be among the hardest to prevent and treat.
Tremeau plans to include endpoints specifically related to the efficacy and safety of TRM-201 in menstrual migraine in its Phase III acute migraine program. Tremeau also plans to study the safety of TRM-201 in people with VWD.
Dysmenorrhea is pain related to menstruation. In up to 15% of women, this pain can be severe enough to limit their ability to participate in school, work, and other daily activities.
The symptoms and impact of dysmenorrhea can be exacerbated in women with bleeding concerns, including women with von Willebrand Disease (VWD). VWD is a bleeding disorder in which the blood does not clot properly. It is the world’s most common bleeding disorder and affects up to 1% of the US population, although mild cases are often undiagnosed. Heavy and prolonged menstruation is the most common symptom in women with VWD, and nearly 40% of women in a CDC-sponsored study reported that their menstrual period limited routine work and social activities, and had a negative impact on their quality of life.
NSAIDs are frequently used alone or in combination with other therapies to treat dysmenorrhea. However, traditional NSAIDs are not recommended in people with VWD and other bleeding concerns because of their inhibitory effect on platelet aggregation.
Tremeau’s development plans for TRM-201 include a safety study in people with VWD.
At Tremeau, we know there are patients and families in need of better non-opioid pain therapies. Because of this need, we are working to bring our investigational therapies to market as soon as possible for eligible patients.
Before we can make our investigational therapies available, we must first conduct clinical trials and obtain approval from the FDA to market those therapies.
Patients who are interested in participating in a Tremeau-sponsored clinical trial should search www.clinicaltrials.gov for planned, active, recruiting, and ongoing trials. When considering any clinical trial, patients should talk with their doctor about potential benefits, risks, and feasibility.
In some circumstances, patients who cannot participate in clinical trials seek access to investigational medicines outside of a clinical trial setting. This is often referred to as “early access,” “expanded access,” or “compassionate use.”
At this time, we do not offer expanded access to TRM-201 or our other investigational therapies. We are focused on developing these therapies so that we can make them available to eligible patients as soon as possible.
Any changes to the policy will be posted to this website. For additional information patients, families or physicians may email us at firstname.lastname@example.org.