A Pittsburg-based drug development company has received U.S. Food and Drug Administration (FDA) approval for phase 3 clinical trials of a product to treat severe, persistent pain. The medication, T-121, is being developed by Thar Pharmaceuticals and is expected to enter the market by 2019. T-121 is an oral version of Novartis’ intravenous-only zoledronic acid, which is sold under the brand name Zometra. T-121 will be intended for patients suffering from complex regional pain syndrome/reflex sympathetic dystrophy (CRPS/RSD), a chronic pain condition often brought on by some sort of trauma. About 70,000 people across the U.S. experience pain from CRPS/RSD, which can become chronic over time and become a disabling condition.
Treatments for CRPS/RSD.
There are many different types of treatments for CRPS and new ones come about relatively frequently, although what works for one does not usually work for another, making treating the condition all the more difficult. Generally, the earlier CRPS is caught and treated correctly, the greater the chance that the condition will respond to medical treatment. Although most doctors agree that a combination of diet, exercise, physical therapy, and medication is the best treatment of CRPS for most patients, exactly what that combination may be and which medications work best is a highly debated issue among pain management doctors. There are no FDA-approved treatments for the pain of CRPS/RSD. Thar Pharmaceuticals developed the drug through the FDA’s orphan disease program, which allows for expedited review, tax credits and other competitive advantages for medications that help fewer than 200,000 people.
CRPS/RSD affects fewer than 200,000 patients in the U.S. each year, according to the National Organization for Rare Disorders.
I have been an advocate for people in pain for eight years. I’m also a caregiver. Over the years, I have noticed a shift in the discussion of opioids; it seems less about patients who use them properly and more about the possibility of abuse. Opioids remain an important option in the treatment of chronic pain,but even patients who take medications as prescribed may feel their access to opioid analgesics restricted.
People in pain need safe, effective and accountable access to the proper medications. While providers, pharmaceutical companies and the Food and Drug Administration (FDA) continue to address abuse issues while ensuring appropriate access to opioid analgesics, there is more that can be done.
An important step is the creation of safer opioid analgesics.Referred to as Abuse Deterrent formulations (ADF), these opioids are developed and formulated to resist alteration and therefore deter abuse. The FDA considers the development of these products a high public health priority. And I agree.
Four Ways to Ensuring Proper Access to Care
Strong and lasting solutions to the opioid health crisis depend on state and national pain policy. I encourage the pain community to help ensure that access to care remains a high priority for the millions of patients who need and take medications responsibly. As advocates, we can:
Help define ADF technology. States need advocates to help define ADF based on FDA guidance.
Support and create legislation which allows non-ADF products from being substituted by pharmacists for ADF,without approval of the prescribing health professional. This legislation should ensure that unless the substituted opioid is also a non-ADF or consent is obtained from the prescribing health professional, a pharmacist would be prohibited from substituting another opioid for an ADF.
Advance patient safety. State legislation should place a high priority on ADF opioid market places where more ADF treatment options exist; and pharmaceutical companies should create these safer medications making them more readily available for pain patients.
Support the removal of barriers to non-opioid therapies as a first line of treatment for pain.
As a leader in the pain community, I work hard to provide access to care for people in pain. I encourage patients and caregivers to learn more about ADF and pain legislation. I hear from patients around the country almost daily who are having trouble filling prescriptions as written. ADF’s can be a step in the right direction. There is a balance between safe opioid use and abuse;but it will require individuals to speak up and take action.