(dailyRx News) Tris Pharma, a privately owned specialty pharmaceutical company, has unveiled a new tool in the nation's fight against opioid abuse. Its new drug delivery platform, NoBuse, offers a technology by which drugmakers can deliver effective pain relief or ADHD products that are nearly impervious to abuse.
In the United States, narcotic pain relievers have fueled a dangerous epidemic. One in five teens has abused a prescription pain medication, and emergency room visits associated with these drugs have increased 163 percent since 1995. The situation has created barriers to access for patients suffering from real pain: Doctors are more reticent to prescribe opioids, and regulators have refused to allow new analgesics on the market unless they have the highest forms of abuse deterrence measures in place.
"In the current environment where opioid abuse has become such a problem, companies must first consider safeguarding their drugs if they want to reach patients in need," says Ketan Mehta, CEO and founder of Tris Pharma. "There's no reason for patients to suffer needlessly when NoBuse provides such an effective option for abuse prevention."
There is a perception that conventional sustained-release formulations are less prone to abuse then immediate-release formulations. However, users can easily extract the full 12- or 24-hour dose from existing sustained-release preparations for immediate consumption and then snort, swallow or inject it, which provides users a high and which can be extremely dangerous when larger-than-intended doses are taken.
The NoBuse delivery system prevents abuse on a physical level without the need for additional ingredients. It employs a technique that reduces the drug to very fine polymeric particles that are coated with a highly flexible, unbreakable film, resulting in particles that are extremely difficult to extract a drug from--even after crushing the tablet or dissolving it in alcohol.
"Abuse of prescription drugs is a fast-growing problem--being able to limit this liability is a real benefit to society," says Thomas Newton, M.D., professor of psychiatry at the Baylor College of Medicine. "Other methods can be breached, but the data for NoBuse shows that it is virtually impossible for abusers to get around. ...the abuse deterrence is not contingent on the patient being forced to take added active ingredients, such as the antagonist naloxone. The vast majority of patients aren't abusers, and there is no reason for them to ingest an additional drug they don't need."
The technology works across a range of oral dosage forms, including tablets, liquid suspensions, orally disintegrating tablets and drug strips. It can also be used to formulate an immediate-release product with a built-in abuse deterrent.