Siponimod, an investigational drug, could add to the treatment options for secondary progressive multiple sclerosis (SPMS) sufferers. A third successful study resulted in the manufacturer seeking approval for marketing the drug soon. In a few years, SPMS patients may have a drug option that slows the rate of disability.
New Drug Study
The latest drug study looked at the efficacy and safety of siponimod. This international trial examined the outcomes of 1651 patients with SPMS. The results showed dramatically slowed progression in siponimod users at both the three- and six-month marks.
This double-blind placebo study was the last in a series of trials to see if the drug could be approved for sale. The manufacturer of siponimod, Novartis, plans to file with regulatory agencies in the United States and Europe for approval to sell the medication sometime this year. Patients with SPMS could be able to receive treatment from the first disease-modifying therapy for their form of MS.
The final trial determined those taking siponimod experienced side effects at a similar rate as those who received a placebo. Of those who took the placebo, 81.5% experienced at least one side effect, while siponimod users experienced side effects at a rate of 88.7%. Side effects that correlated to taking siponimod include hypertension, macular edema, convulsions, reduced number of immune cells, varicella, slower heart rates and higher liver enzymes.
What Is Multiple Sclerosis?
Multiple sclerosis is a condition affecting the nervous system. Currently, it has no cure, but medications control the symptoms. Three main types affect the 2.3 million people around the world with this condition: Relapsing-Remitting (RRMS), Primary Progressive (PPMS) and Secondary Progressive (SPMS). Both progressive forms gradually get worse over time, causing severe loss of mental and physical capabilities.
Though RRMS is the most commonly diagnosed form, it progresses into SPMS in 75% of patients within 30 years. SPMS is marked by a continual worsening of mental and physical functioning. The disability caused is permanent, with no cure. The only treatment for SPMS is to slow the rate of progression.
How Does Siponimod Work?
Since MS occurs when immune cells attack the spinal cord and brain, siponimod acts to reduce the activity of a pair of receptors on immune cells. Lowering the activity level of these receptor keeps the cells from reaching the brain. The result of this process is a reduction in inflammation in the nervous system that marks SPMS.
What Is an Investigational Drug?
The FDA approves investigational drugs for human trials only after proving their efficacy in animal studies. Technically termed, investigational new drugs (IND) medications fall into two categories:
- Commercial Drugs: Will be sold and are often sponsored by the company who will market them
- Research Drugs: Often are existing drugs that require human trials to test off-label uses
INDs that show positive performance in a pair of human trials may apply to the FDA for marketing. At this stage, the FDA formally reviews the drug and decides if it’s safe for sale. Siponimod has reached this level after success in its Phase 3 trials. If approved, siponimod could be available to MS patients soon.
Current Treatment Options for MS
Treatments for SPMS exist today, but they vary in their degrees of success. Patients often feel frustrated when their current treatment plans do not provide the desired relief. Doctors tailor the drugs a patient takes to improve lifestyle. Until now, physicians had no medication for SPMS patients that could slow the progression of the disease. This highlights the need for alternative treatment options for SPMS.
This new study shows the promising future of MS treatment. The addition of siponimod to the treatment options for SPMS will benefit those with the most debilitating form of the disease. Slowing the disease’s progression can help these people live longer, fuller lives.