Four drug companies are in the process of developing a pain killer that is ten times stronger than Vicodin which contains hydrocodone and acetaminophen. This new drug will the first on the market to contain pure hydrocodone without acetaminophen.
Zogenix has completed three rounds of patient testing, and last week they announced they met with the Food and Drug Administration officials for the final meeting to talk about the upcoming drug application. Zogenix plans to file the drug application in early 2012 and have Zohydro on the market by early 2013.
About Zohydro: Zohydro is a novel, oral, single entity (without acetaminophen) extended-release capsule formulation of hydrocodone bitartrate. When used in high dosages over time, acetaminophen can cause liver toxicity. If approved, Zohydro could be the first single-entity hydrocodone therapy available. Zohydro uses Alkermes’ patented Spheriodal Oral Drug Absorption System (SODAS®) drug delivery technology which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate release combination products. Capsule strengths utilized in the Phase 3 studies included 10, 20, 30, 40 and 50 mg capsules.
The other companies that are in the process of making this hydrocodone drug are: Perdue Pharma, Cephalon, and Egalet.
Purdue Pharma and Cephalon are in late-stage trials of their own hydrocodone drugs, according to documents filed with the Food and Drug Administration. In May, Purdue Pharma received a patent applying for extended-release technology to hydrocodone.
Egalet has finished the most preliminary stages of safety testing and could have a product on the market as early as 2015 but they would like to see how the other companies get treated by the FDA before they move forward with producing the drug.
The latest drug tests come as more pharmaceutical companies are getting into the $10 billion-a-year legal market for powerful and addictive opiate narcotics reported by Tennessean. “It’s like the wild west,” said Peter Jackson, co-founder of Advocates for the Reform of Prescription Opioids. “The whole supply-side system is set up to perpetuate this massive unloading of opioid narcotics on the American public.”
This new time released drug raises some fears with hydrocodone addiction becauses users can crush it and get an immediate high. “I have a big concern that this could be the next OxyContin. We just don’t need this on the market,” said April Rovero, president of the National Coalition Against Prescription Drug Abuse.
In 2000, there were 19,221 emergency room visits as a result of hydrocodone abuse. In 2009 the number increased drastically to 86,258 visits. Between 2003 and 2007 in the state of Florida, hydrocodone caused 910 deaths and contributed to 1,803 others. These figures are according to the DEA.
Hydrocodone side effects can be serious if not used in the correct way. Some hydrocodone side effects include: Anxiety; constipation; diarrhea; dizziness; dry mouth; gas; headache; heartburn; increased sweating; loss of appetite; nausea; nervousness; stomach pain or upset; trouble sleeping; vomiting; weakness.
You should seek medical attention right away if any of these severe side effects from hydrocodone occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; blurred vision; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slow or shallow breathing; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.
Examples of how severe Hydrocodone addiction has become reported from drug-addiction.com: An estimated 7 million dosage units were diverted in 1994 and over 11 million in 1997.
In 1998 there were over 56 million new prescriptions written for hydrocodone products and by 2000 there were over 89 million.
From 1990 the average consumption nationwide has increased by 300%. In the same period there has been a 500% increase in the number of Emergency Department visits attributed to hydrocodone abuse with 19,221 visits estimated in 2000.
In 1997, there were over 1.3 million hydrocodone tablets seized and analyzed by the DEA laboratory system.