Opexa Therapeutics, Inc. (NASDAQ:OPXA) is a publically traded biotechnology company developing personalized immunotherapies with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases, such as neuromyelitis optica (NMO). These therapies are based on Opexa’s proprietary T-cell technology. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of Secondary Progressive MS.
Opexa’s mission is to lead the field of Precision Immunotherapy™ by aligning the interests of patients, employees and shareholders.
Armodafinil – a novel replacement for Modafinil
With Modafinil being at the height of it’s sales, it’s no wonder that many other countries have sought to replicate the famous US based Modafinil brand known as Provigil. The modafinil patent is still going strong with Cephalon maintaining it’s strong hold on Provigil with twelve suppliers and two patents protecting the drug. However, some countries (namely China and India) do not respect international drug patents, and have managed to influence the modafinil market by introducing many generic version of the drug.
Since Modafinil’s rise in the late 90’s generic versions have been readily available to the public. Modalert, Alertec and Modvigil are among a growing number of cheaper alternatives to the already expensive Provigil. Modafinil – being relatively cheap to synthesize has not suffered the same fate as some other India replica medications. The public are not worried about the purity of generic modafinil like they may fear of other drugs such as Viagra. This is because modafinil is so low in manufacture costs, and so well known to the user, that Indian pharmacies do not feel the need to create fake pills. Due to the huge off label use of Modafinil and the widespread public purchase through offshore pharmacies, major drug company Cephalon have fought back. A new drug called Armodafinil has been created in response to the large body of research suggesting modafinil’s safety and off label use. Marketed as a longer acting version of modafinil, armodafinil is used in the treatment of the same symptoms, namely excessive daytime sleepiness, narcolepsy and chronic fatigue syndrome. The main pharmacological difference between the parent compound and armodafinil is the half life. Modafinil has a half life of approximately 4-6 hours, with armodafinil topping this with approximately 6-12 hours action.
The brand name for the newly marketed alternative is Nuvigil, with the official website claiming “NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to shift work disorder”. Online reports have indicated that Nuvigil indeed has a longer duration of action, with healthy volunteers moving over to the new drug from their current modafinil regimen.
In keeping with the global modafinil situation, many generic forms or armodafinil have since hit the market. Brands such as Artvigil and Armod have flooded the online marketplace, offering 150mg pills at a fraction of the price of Nuvigil. What’s more is that prospective customers are able to acquire these generic brands with relative ease; a simple google search followed by a credit card payment allows for fast global shipping and a thriving user base who are able to buy modafinil as and when it it needed.
The current nootropic landscape is awash with propaganda hype and active user discussion. Gone are the days of prescription only medication for those suffering from specific ailments. A new subset of modafinil and armodafinil users have flooded the market. There is no doubt that armodafinil will continue to grow in popularity with speculation of more modafinil-like drugs in the pipeline.
NICE Guidelines: Zopiclone (Imovan) Risks Dependence and Withdrawal
National Institute for Health and Care Excellence (NICE) guideline commission (“Medicines Associated with Dependence or Withdrawal Symptoms: Safe Prescribing and Withdrawal Management for Adults”) reports that Zopiclone (Imovan,) a sleep aid sold in 5-7.5mg tablets under the brand names Imovan, Zimovane, and Dopareel, is associated with dependence and withdrawal symptoms.
Zopiclone sleep aids are highly effective and used to treat chronic insomnia. Zopiclone is a nonbenzodiazapine hypnotic drug, which are generally considered to be less addictive. However, zopiclone and other drugs in the Z-class, such as opioids, gabapentin, and pregabalin, are presently recommended to only be prescribed for short periods.
Zopiclone side effects include nausea, vomiting, dizziness, rashes, drowsiness, dry mouth, and headaches. Occasionally, zopiclone has been linked to amnesia, slurred speech, blurred vision, confusion, depression, hallucinations, and nightmares. Zopiclone can also cause lightheadedness, issues with balance, and sleepwalking, which can cause falls. Withdrawal symptoms of zopiclone include feelings of edginess, mood swings, strong cravings lasting 6-8 days, and both increased insomnia and undesired wakefulness.
“Although these medicines can provide lasting symptom management for a proportion of people taking them, they do not work for everyone,” states Dr. Paul Crisp, Director of the Center for Guidelines at NICE, “Many people continue to be prescribed these dependence-forming medicines despite evidence that the risks associated with adverse advents of them outweigh their benefits.”
According to the new NICE guidelines, 9/10 people on zopiclone and other z-class drugs are on them unnecessarily. Because of this low precision in prescribing, the commission recommends weaning patients to a lower dose (7.5mg to 5mg) before ceasing zopiclone entirely. By highlighting the over prescription of Z-class drugs, the new NICE guidelines should promote precision medicine of these potentially addictive medications, reducing the ratio of people on these medications unnecessarily.
“Having the right strategy for withdrawing safely from these medicines is key and that is why these evidence-based guideline recommendations are required to support healthcare professionals and patients,” said Dr. Crisp.
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