Today, more people are getting hooked on prescription medications than illegal drugs, prompting this small-cap pharmaceutical company to develop innovative products that are abuse-resistant…
The United States has a hard enough time trying to make inroads into the dangerous and deadly world of illegal drugs — now they’re being forced to direct their attention to controlled prescription drugs as well.
Depending on who you speak with, there’s been little progress made in the battle against narcotics, with the exception of marijuana legalization in some US states.
But it’s the drugs that can be legally obtained at pharmacies and dispensaries that are quickly becoming the more severe problem throughout America.
According to the Drug Enforcement Agency’s (DEA) annual Drug Threat Assessment Summary survey, prescription drug abuse is the nation’s fastest growing drug problem, and second only to marijuana in terms of prevalence.
The most common types being abused are painkillers, which unsurprisingly, are also involved in the greatest number of overdose incidents in the country.
Over 28% of law enforcement agencies who responded to last year’s survey declared controlled prescription drugs to be the greatest drug threat, up from under 10% in 2009.
Judging from the stats compiled by the National Survey on Drug Use and Health (NSDUH), it’s not hard to see why…
- prescription-related treatment admissions rose 68% between 2007 and 2010
- prescription-related emergency admissions rose 91.4% between 2006 and 2010
- 6.1 million people (or 2.7% of the US population) aged 12 or older are identified as nonmedical users of psychotherapeutic drugs
- Of the 6.1 million: 4.5 million used pain relievers, 1.8 million used tranquilizers, 970,000 used stimulants, and 231,000 used sedatives
- Disbursements have been on the rise between 2007 and 2011 due to the proliferation of rogue pain management clinics (aka pill mills) and online pharmacies which often sell drugs without requiring valid prescriptions
The various agencies also reported that access to prescription drugs has become more widespread throughout the country, with availability soaring from 40.7% in 2007 to 75.4% in 2013.
There have been a number of attempts to try and combat abuse, including nationwide pill amnesty campaigns and Internet search engines blocking ads of non-verified pharmacy sites.
But such measures to curb inappropriate drug use have been feeble at best.
In turn, this has made it more challenging for pharmaceutical companies to get new products approved by the US Food and Drug Administration.
The FDA has been particularly tough on medications related to pain relief since these products are being misused the most, but one pharma refuses to throw in the towel.
Their flagship trial candidate has already been rejected multiple times by the FDA, but their third attempt could be the charm as the Company is determined to help reverse the trend of prescription drug abuse.
Top Pharmaceutical Stock To Buy Today:
Pain Therapeutics, Inc. (NASDAQ:PTIE) currently has four products undergoing clinical trials, and has yet to have any drugs approved by the FDA.
However, one of them is getting much closer.
Pain first unveiled Remoxy in the mid-2000s. Remoxy is an extended-release version of the painkiller oxycodone, and its development is bankrolled entirely by Pfizer Inc. (NYSE:PFE).
During that time, the issue of CPD abuse began to really take hold in the industry, resulting in Remoxy’s first FDA rejection in 2008
And so a few changes to the formula were made to try and ease the FDA’s worries.
Remoxy was reformulated to make it harder to crush down and to have a more off-putting taste – thus mitigating the propensity for snorting.
Even though it was rejected a second time, Pfizer recently threw its full weight behind Remoxy and made a decision last October to push forth with a third attempt at FDA approval.
Pfizer was obviously confident that they’re close to an approval, so they announced that they would fund additional clinical studies to determine the safeness Remoxy.
According to Pain’s management, “…these new clinical studies will include, in part, a pivotal bioequivalence study with the modified Remoxy formulation to bridge to the clinical data related to the original Remoxy formulation, and an abuse-potential study with the modified formulation.”
The third FDA decision is expected sometime in mid-2015, so investors can expect a great deal of buzz growing with each word of Remoxy’s progress over the coming year.
Clearly, Pfizer is all in.
Even though they’ve already doled out $185 million to date to pay Pain for Remoxy’s development milestones and program fees over the last seven years, that’s peanuts compared to the potential billions these companies can make off of this one drug.
Keep an eye on this one.
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