News and Whitepapers

The U.S. Food and Drug Administration (FDA) is warning that serious breathing problems have been associated with gabapentinoids such as oral gabapentin and pregabalin when used with CNS depressants or in patients who have respiratory risk factors. These warnings are based on a review of several sources of data including case reports submitted to the FDA or published in the medical literature, observational studies, human trials and animal studies. Gabapentin and pregabalin are FDA-approved for a variety of conditions, including seizures, nerve pain, and restless legs syndrome. (click to learn more)

Topical Gabapentin use on CRPS

Gabapentin is one of the most commonly prescribed pain medications for neuropathic pain in general, and specifically in Complex Regional Pain Syndrome (CRPS). Gabapentin is thought to work by modulating calcium channels at a specific alpha delta subunit. CRPS 1 is a disabling syndrome, in which a painful limb is accompanied by varying symptoms. Neuropathic pain is a prominent feature of CRPS I, and is often refractory to treatment. Topical delivery of gabapentin is desirable to treat peripheral neuropathic pain conditions while avoiding systemic side effects. (click to learn more)

Cascade with GI Prostaglandin and Use of Topical NSAIDs vs Oral NSAIDs

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used for their anti-inflammatory, analgesic, and antipyretic effects. NSAIDs generally work by blocking the production of prostaglandins (PGs) through the inhibition of two cyclooxygenase enzymes. However, their use has been associated with potentially serious dose-dependent gastrointestinal (GI) complications such as upper GI bleeding. GI complications resulting from NSAID use are among the most common drug side effects in the United States, due to the widespread use of NSAIDs. Topical products were developed to provide well tolerated, effective targeted therapies, based on the drug’s pharmacokinetics and penetration to the site of action. (click to learn more)

Dexamethasone Iontophoresis

Iontophoresis of dexamethasone is routinely used in physical medicine and rehabilitation as a treatment modality for patients with various musculoskeletal inflammatory conditions. Dexamethasone iontophoresis therapy has been utilized for more than 30 years to treat various musculoskeletal conditions, including tendinitis, epicondylitis, enthesitis, and inflammatory peripheral arthritis. (click to learn more)

New ACP Guidelines for Treatment of Acute Non Low Back Pain-Topical NSAIDs First-Line Therapy

The American College of Physicians (ACP) and American Academy of Family Physicians (AAFP) recommend topical nonsteroidal anti-inflammatory agents (NSAIDs) as the first-line of therapy for non-low back pain. Physicians should encourage adults to use NSAIDs, particularly topical ones, to treat acute non-low back pain that stems from musculoskeletal injuries, according to the new guidelines. (click to learn more)

Topical Gabapentin

Topical Gabapentin is used for the treatment of chronic pain conditions including but not limited to postherpetic neuralgia (PHN), complex regional pain syndrome (CRPS) and vulvodynia (VVD). Multiple studies have already demonstrated the efficacy of oral gabapentin in treating chronic neuropathic pain. However, oral gabapentin is limited by dose-dependent toxicity which can cause systemic adverse effects. (click to learn more)

Topical Ketoprofen

Ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), possesses analgesic, antipyretic and anti-inflammatory properties. Oral Ketoprofen is widely used in musculoskeletal pain and inflammation in muscles and joints, including arthritis pain, osteoarthritis, stiffness of the joints, soft tissue rheumatism, and sports injuries. Topical formulations of NSAIDs have analgesic effects similar to that of oral formulations, but are associated with less systemic exposure and, therefore, with fewer serious adverse events. (click to learn more)

Why Gabapentin may become a Schedule V controlled substance

Gabapentinoids (e.g. pregabalin and gabapentin) are widely used in neurology, psychiatry and primary
healthcare but are increasingly being reported as possessing a potential for misuse. Gabapentin may be
abused for its euphoric and analgesic effects, or to substitute for or potentiate the effects of opioids or
methadone. Gabapentinoids are thought to possess GABA-mimetic properties whilst possibly presenting with
direct/indirect effects on the dopaminergic 'reward' system. (click to learn more)

Unapproved vs Approved Drug Products, “What does it mean?”

There are products on the market today that are approved for pre-market conditions and products that have not been approved for pre-market conditions thus titled “unapproved” according to FDA Guidelines. Approved products go through a New Drug Application process (NDA) for pre-market claims. Unapproved products meet conditions under, Generally Recognized as Safe and Effective (GRASE), regardless of the route, these products are both legally acceptable and compensable in today’s market. (click to learn more)

Topical Cyclobenzaprine

Cyclobenzaprine is a skeletal muscle relaxant pharmacologically related to tricyclic antidepressants. It acts centrally to reduce somatic motor activity by influencing both alpha and gamma motor neurons. Cyclobenzaprine is often compounded into topical analgesics (off-label use) for musculoskeletal conditions because it is highly effective in muscle tissue at the site of pain, allowing for effective dosing without the systemic adverse effect of somnolence. A potential advantage of topical agents is avoidance of the systemic side effects often associated with oral medications. (click to learn more)

Topical Tramadol

Opioids are the most powerful pain relievers, and therefore, traditional opioid analgesics remain the drug of choice for the medical treatment of severe acute pain syndromes and for progressive severe chronic illnesses. As a molecule, based on its physicochemical properties, tramadol appears to be a suitable transdermal agent. Also, its pKa is about 9.41; therefore, it is ionized and soluble over the pH range of interest. Topical approaches have the advantage of local pain control with minimal systemic side effects and good patient acceptability. (click to learn more)

Low Vitamin D Levels Found to Increase Risk of COVID-19

Vitamin D is recognized as an important co-factor in several physiological processes linked with bone and calcium metabolism, and also in diverse non-skeletal outcomes, including autoimmune diseases, cardiovascular diseases, diabetes type 2, obesity and cognitive decline and infections. In a large, population based study it has been determined that low plasma vitamin D levels have emerged as an independent risk factor for COVID-19 infection and hospitalization. "Suboptimal" or "low" plasma 25(OH)D level was defined as plasma 25-hydroxyvitamin D, or
25(OH)D, concentration below the level of 30 ng/mL. (click to learn more)

Topical Amitriptyline in Neuropathic Pain

There are several articles that support the use of topical amitriptyline. Topical amitriptyline acts mainly locally in tissues through receptors and/or ion channels. Analgesics administered topically have a much better profile for adverse effects as they relieve local pain with minimal systemic effects. (click to learn more)

Why is a Topical Treatment Plan Preferred?

Topical preparations have a good safety profile, which may decrease systemic side effects and are beneficial for patients who are intolerant or want an alternative to oral medication. To achieve the benefits and results of topical preparations it is important to follow the exact instructions of the physician, since “favorable treatment outcomes are strongly dependent on medication adherence rate”. (click to learn more)

Plasma Concentration of Oral Gabapentin Dose Not Increase Proportionally with Increase Dosing

The gabapentinoids are often recommended as first-line treatments for the management of neuropathic
pain. The differing pharmacodynamic and pharmacokinetic profiles can have implications for clinical
practice. Gabapentin, as an oral preparation, is absorbed in the small intestine by a combination of diffusion
and facilitated transport. Oral bioavailability for gabapentin is between 30-60%. As the dose of gabapentin
increases, the area under the plasma concentration–time curve (AUC) does not increase proportionally. (click to learn more)

Topical Diclofenac

Non-steroidal anti-inflammatory drugs (NSAIDs) are a group of therapeutic agents that have analgesic, antipyretic and in high doses anti-inflammatory actions. Diclofenac is available today as various topical formulations in the form of gels, gel patches, sprays, foams, creams, ointment etc. They are effective and at the same time well tolerated by the patient. (click to learn more)

FDA says NSAIDS increase risk of heart attack

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Nonsteroidal anti-inflammatory drugs (NSAIDs) are drugs with analgesic, anti-inflammatory, and antipyretic activity. (click to learn more)