Canadian pharmaceutical company M. Pharmaceutical Inc. is pushing a new formulation of the wildly popular obesity-control drug Orlistat through expedited clinical trials. If the drug successfully completes trials, it may be available by mid-to-late 2018.
What is Orlistat?
Orlistat is an obesity treatment drug that prevents dietary fat from being absorbed into the body after consumption. The drug’s mechanism begins with the inhibition of pancreatic lipase, an enzyme essential to the breakdown of triglycerides in the intestinal tract. Hydroxylation of triglycerides into fatty acids that can be absorbed by the body cannot occur without this enzyme, so the body turns excess fat into waste and excretes it.
Orlistat became unpopular when the malabsorption of fat began to cause gastrointestinal problems for users. Common side effects of the original Orlistat include frequent bowel movements, bowel urgency, oily evacuation, steatorrhea, oily rectal leakage, and flatulence with discharge. Because these common side effects were so unpleasant and interfered with everyday life for Orlistat users, original sales of $900 million dropped to nearly $200 million in recent years.
Does Orlistat Work Against Obesity?
Orlistat has shown efficacy in clinical trials and modern medicine to have a positive effect on BMI and overall health when combined with a low-calorie, low-fat diet and exercise. However, obesity rates are still on the rise, and the unpleasant side effects of Orlistat may be to blame for its lack of effect on obesity statistics.
As of September 2015, 3 states in the US have rates of obesity over 35%. Every state has reached rates above 20%, and most of those states range between 25% and 30%. Though Orlistat has many success stories and positive results, the rise of obesity outpaces current treatment.
How the New Formula Will Change Obesity Treatment
The newly formulated Orlistat remains untested, but the hope of M. Pharmaceutical Inc. is that the uncomfortable side effects of fat malabsorption will be mitigated or eliminated by the revamped formula. The company was able to negotiate the use of previous data collected on the previous Orlistat formula to put it through an expedited approval process via the Food and Drug Administration (FDA) for entry into the pharmaceuticals market.
The medication will still be thoroughly tested with supervision by the FDA. The main objective of the drug manufacturer will be to prove to the FDA that the side effects have been eliminated while the full efficacy of the original formula remains. The process could take as little as 2 years, which would allow those being diagnosed with obesity now to seek treatment through medication with the new Orlistat toward the middle of their treatment process.
If the medication achieves success, it may be able to return sales of the drug to the original numbers and offer a solution for the increasing prevalence of obesity in America. If the drug regains its popularity, it may be a tool to help slow the growth of obesity without causing mental and physical strain to patients. Once the weight loss drug is tested, more information on the outcome of the new Orlistat drug will be released.