One study open assessing like ability and that study is not recruiting since it's all but closed out.
It would be great for PFE to state at next conf call all studies completed, data good & working on CRL response package.
I failed to note in my prior post that, in the course of PTIE's August 5 Q2 conference call, Barbier alluded to another patent that had just been filed in connection with the vaunted "new product candidate". I suspect that (when,as and if) the application is accepted for filing that a press release will be forthcoming.
PTIE filed two patent applications this July:
# 20140193490 7/10/14
# 20140186437 7/3/14
The description of both patent applications is identical:
"ORAL DOSAGE FORMS WITH THERAPEUTICALLY ACTIVE AGENTS IN CONTROLLED RELEASE CORES AND IMMEDIATE RELEASEGELATIN CAPSULE COATS - The present invention relates to oral dosage form with active agents in controlled release cores and in immediate release gelatin capsule cores."
Could this development be related to PTIE's vaunted new product to be revealed later this fall?
Experts Say Cannabis for Pain Requires Better Science
Further research is needed to clarify the mechanisms of action of the various cannabinoid molecules as well as the potential for clinically relevant therapeutic effects, according to a presentation at the 2014 European League Against Rheumatism Con gress. This research can lead to improved awareness of the potential benefits and risks of the various components of marijuana for the treatment of pain.Paris—Although #$%$ (Cannabis sativa) is now prescribed in 23 states in the United States for pain relief for musculoskeletal and arthritic conditions, cancer, headache and other conditions, there is limited evidence to support its use, say some experts. This is especially true for use in individuals with musculoskeletal complaints.
“When thinking of herbal cannabis specifically, there are currently no studies in patients with rheumatic conditions that can assist physicians to competently and safely advise patients,” said Mary-Ann Fitzcharles, MB, ChB, Division of Rheumatology and Alan Edwards Pain Management Unit, McGill University, Montreal, Quebec, Canada. “Unfortunately, various jurisdictions have required physicians to accept responsibility for prescribing herbal cannabis, or for caring for patients who may be using medicinal herbal cannabis in the absence of sound advice. Therefore, in the absence of the usual [research] that is required for any other therapeutic agent worldwide, physicians must project a message of extreme caution that should focus on the need to protect both the patient and society.”
The only information on herbal cannabis use in rheumatic conditions is based on a few small population studies of “users,” with self-reported diagnosis and self-reported outcome measures, Dr. Fitzcharles said. Furthermore, there is little information on the quantity or quality of the agent used, and methods of administration, as well as often a lack of clarity for true reasons for use, as many users report previous recreational marijuana use.
The need for further research is clear, she continued, especially for pain in rheumatic conditions. There is only one quality study on the role of nonherbal cannabinoids in rheumatoid arthritis, for example, and only five in fibromyalgia, she told meeting attendees; of those eight studies, only three were identified as randomized controlled trials.
A recent survey of family physicians in the state of Colorado, where marijuana is legally prescribed, showed that most respondents were not convinced of the benefits of marijuana and wanted further education about it (J Am Board Fam Med 2013;2:52-60).
The general term “cannabinoids” includes endocannabinoids (naturally occurring in bodily systems), phytocannabinoids from the plant (herbal marijuana) and synthetocannabinoids (pharmaceutical preparations). Among the components of cannabinoids, delta-9-tetrahydrocannabinol (Δ9-THC), commonly referred to as THC, is psychoactive, whereas cannabiol is weaker in this regard and may have considerable therapeutic effects.
Herbal cannabis is most often inhaled, either smoked or via a vaporizer, but can also be ingested in baked products or as a tea infusion. The oromucosal spray of nabiximols, a combination of Δ9-THC and cannabidiol, is a pharmacologic preparation sprayed under the tongue.
Pharmacologic preparations are more desirable than herbal ones, said Dr. Fitzcharles; the former are controlled regarding quality and dosing, and have been evaluated for efficacy and safety, whereas the latter are largely uncontrolled. Pharmacologic preparations are more likely to deliver quantifiable and consistent amounts of active drug than herbal cannabis. Additionally, they avoid the negative health effects associated with smoked herbal cannabis, due to the inhalation of polycyclic aromatic hydrocarbons, tar and carbon monoxide.
Other health risks associated with use of herbal cannabis include compromised cognition and psychomotor function (a risk associated with higher rates of driving accidents), cardiovascular effects (tachycardia and hypotension) and long-term risk to respiratory function and psychological health.
“It’s a myth that one can’t become dependent on cannabis,” said Dr. Fitzcharles. “Dependence occurs in at least 8% of recreational users by one year, and may alert society to the abuse potential of pharmacologic preparations. Some of the pharmaceutical cannabinoid products—dronabinol and nabiximols—also have modest abuse potential.”
Endocannabinoids are found throughout the body. There are two endocannabinoid receptors: The CB1 receptor is found in the nervous system and in joint tissue and has effects on pain and bone health, whereas the CB2 receptor is found mostly on immune cells with less understood function.
“The presence of both receptors and endocannabinoid ligands in joint tissue indicates that the endocannabinoid system is probably important in rheumatic diseases,” Dr. Fitzcharles said.
Herbal cannabinoids pose many unanswered health-related and societal questions, she added. Their potential risks and benefits suggest that research is needed to identify compounds with more targeted effects and fewer psychoactive and other negative effects. Dr. Fitzcharles urged health professionals to advocate for more research.
Commenting on the presentation, Neal Birnbaum, MD, Division of Rheumatology, California-Pacific Medical Center, in San Francisco, agreed that more research is needed and said that more responsible prescribing by doctors is also required.
“It is common for physicians to prescribe narcotics and #$%$ in my state, where it is legal,” Dr. Birnbaum said. “But this is often done loosely without considering all the risks and benefits. There can be serious consequences with little benefit.”
Hey Boring. So after 6 years of denial you are eventually coming around to my way of thinking about Remi and cannabinoids. All that self testing in the lab is perhaps paying dividends.
My thought is PTI-609 is their mystery product:
PTI-609 is a novel drug candidate with strong analgesic properties and no discernible addictive properties compared to morphine in standard animal models of assessing reward.
I had meant to post this senence as a preface to my last post:
Barbier has a history of waxing philosophic about the efficacy of cannabinoids in combination with opioids for the treatment of chronic pain. Below is another perspective on this issue from the website cornerstonecollective: PTIE"s "new, novel" opioid drug candidate - to be revealed later in Q3 - may very well be a "next generation" variant of a cannabinoid/opioid combo ER painkiller.
Cannabinoid-Opioid Interaction in Chronic Pain, A Review
Everyone knows that cannabis delivers various medical benefits, perhaps the most important one being pain relief. Other drugs relieve pain, and doctors normally prescribe opiates or opioids to relieve severe pain. However, opioid side effects include sedation, nausea and vomiting, and addiction.
Nevertheless, the medical and cannabis communities have good cause to learn more about the combined use of cannabis and opioids. Research has shown that cannabis enhances the pain relief of opioids while reducing nausea (Narang, 2008). Patients may benefit from the cannabis-opioid combination by being able to reduce their use of the opioids and the side effects they cause. Many patients already augment their opioid pain relief regimen with cannabis, so the interaction deserves close examination.
For some patients, psychoactivity poses the most serious side effect of cannabis. Beyond that, patients can safely obtain pain relief from cannabis precisely because it has few other side effects. The inherent safety of THC is due to the scarcity of cannabinoid receptors in the parts of the brain that control metabolism and breathing.
In 2010, Dr. Donald Abrams conducted a study using 24 patients at the San Francisco General Hospital. The patients normally consumed morphine or oxycodone for significant pain due to various conditions (cancer, multiple sclerosis, migraine, etc.). The study examined the subjective effects on the patients following the addition of inhaled cannabis vapor to their opioid regimen. The patients inhaled vaporized cannabis three times a day for five days. The patients also continued their prescriptions of sustained release tablets of morphine or oxycodone.
The authors justifiably proclaim that “This is the first human study to demonstrate that inhaled cannabis safely augments the analgesic effects of opioids.” Indeed, this area deserves much more research.
The study found that cannabis reduced pain 40% on the first day, and after 5 days continued to reduce pain 27%. The patients treated with the cannabis-morphine combination experienced more consistent pain relief than the patients that received the cannabis-oxycodone combination. Cannabis and morphine pain reduction continued at about 33% throughout the 5 day trial. In contrast, cannabis and oxycodone pain reduction dropped from 44% to 21% by Day 5.
The “high” felt on the first day dropped to a tenth of the original level by Day 5 for morphine, and dropped to a third of the original level by Day 5 for oxycodone. Presumably, the patients taking oxycodone would experience still less of the high if the trial continued past five days. The fact that the high or the inebriation declines over time demonstrates the practical use of cannabis with opioids. Patients who dislike the high can merely get past the first few days to enhance their opioid with a minimum of “impairment.” In time, perhaps no feeling of inebriation would remain. If that is true, higher doses of cannabis could provide even greater relief, and a greater reduction in opioid consumption. Given the need to improve pain management and the absence of cannabis toxicity, much more work with cannabis is merited.
Cannabinoids and opioids share the effects of pain reduction, sedation, lowered body temperature and lowered blood pressure. THC slows gastrointestinal motility and thus can slow the absorption of orally administered drugs. THC also seems to help certain drugs to get into the brain, perhaps because of the vasodilation (temporary thinning of the blood vessel walls). The vasodilation effect of THC causes the reddening of the eyes as the eye capillaries enlarge.
As the reader may expect, a five-day trial can only provide a near-to-moderate time frame in which to observe effects. The study also could have been limited by only using vaporization as the means of consumption. The study made no attempt to avoid a placebo effect. In general, studies that involve vaporizing or smoking cannabis cannot employ blind or double blind methods because of the “high.”
The study only used 24 volunteers, a number below that needed to generate good statistics. Reliable statistics generally require a sample size of thirty or more. Below thirty, statistical findings cannot establish confidence levels above 90 percent. Nevertheless, small clinical studies provide the direction for larger, better funded studies.
Still another weakness related to the timing of two drug effects. Inhaling THC produces a rapid and strong blood concentration while consuming opiate orally produces a maximum effect an hour or three after ingestion. Indeed, another study (Narang, 2008) tested opioids with oral THC (synthetic Dronabinol) and this study also demonstrated significant decreases in chronic pain.
For the purposes of relieving pain alongside opioids, orally administered THC may be preferred by some patients over inhaled THC. On the other hand, oral consumption of THC suffers from decreased control over the dosing, absorption being strongly affected by the types of food consumed and by patient metabolism.
Other issues worthy of comment include the following: Some research indicates that cannabinoids increase endorphins, the neurotransmitters that opioids mimic. And yet, research has clearly distinguished the CB1 and CB2 receptors (cannabinoid receptors) as being entirely different from those affected by opioids. The interactions of CBD or other cannabinoids with opioids remains unexplored and will surely yield very exciting discoveries.
It is important to reinforce the finding that even within a week, the psychotropic effects of the THC decreased much more than the pain-relieving effects. In the near absence of toxicity, the THC dose can be safely increased to compensate for the reduction in the “high.” The few patients who dislike the THC inebriation can expect to get improved pain relief without the high after a few days.
In summary, this study provides an important benchmark in showing the value of inhaled THC to help opioids relieve pain.
Abrams, D. I., et. al. Cannabinoid-opioid interaction in chronic pain. Nature 90:6, 844-851 (Dec 2011). Narang, S., et. al. Efficacy of Dronabinol as an adjuvant treatment for chronic pain patients on opioid therapy. J. Pain 9,254-264(2008).
article source: htt
Could an opioid/marijuana combination drug be PTIE's secret new product?
The article below appeared in yesterday's LA Times:
Could #$%$ be an antidote for the nation's scourge of fatal overdoses caused by prescription pain medication? A new study suggests the answer is yes, and it's set off a flurry of medical debate over the risks and benefits of making cannabis more widely available to patients.
The new research, published Monday in the journal JAMA Internal Medicine, finds that deaths associated with the use of opiate drugs fell in 13 states after they legalized #$%$. Compared to states with no formal access to marijuana, those that allowed certain patients legal access to cannabis saw a steady drop in opiate-related overdoses that reached 33%, on average, six years after the states' #$%$ laws took effect.
Related story: DEA tightens controls on hydrocodone painkiller drugs
"The striking implication is that #$%$ laws, when implemented, may represent a promising approach for stemming runaway rates of nonintentional opioid-analgesic-related deaths," wrote opiate abuse researchers Dr. Mark S. Brown and Marie J. Hayes in a commentary published alongside the study. "If true, this finding upsets the apple cart of conventional wisdom regarding the public health implications of marijuana legalizations and medicinal usefulness."
That apple cart has already been shaken by a growing body of research that suggests marijuana's psychoactive ingredients may enhance the pain-killing effects of opiate drugs, allowing patients using marijuana for pain to take lower — and less dangerous — doses of opiate medications.
"It's so apparent that our patients can decrease, diminish or wean themselves completely off of opiates, and that it improves their quality of life," said Dr. Donald Abrams, a UC San Francisco oncologist who was not involved with the study.
But those who have opposed expanding access to #$%$ said they were not persuaded that cannabis — a plant designated by the Drug Enforcement Agency as having "no recognized medicinal use" — is a safer alternative to opioids.
"Clearly the study raised an intriguing hypothesis, but many questions still need to be answered," the National Institute on Drug Abuse said in a statement released Monday. The analysis "should not be oversimplified," the statement warned.
Patients in 23 states and the District of Columbia now have the option of seeking a prescription for #$%$. (Two of those states, Colorado and Washington, also allow recreational use of the drug.) Chronic pain is thought to be the leading indication for cannabis use.
The study authors, led by the University of Pennsylvania's Dr. Marcus A. Bachhuber, focused on the years 1999 to 2010. The raw figures collected from states' death certificates showed that rates of fatal opioid overdoses were higher in the states that had implemented #$%$ laws than in those that had not.
The results showed that after a state began to implement a #$%$ law, the rate of its non-intentional opiate overdose fatalities fell compared to those of states without such laws.
And that comparative decline picked up steam over the first six years after the laws went into effect. On average, the statistical analysis showed, states passing #$%$ laws saw annual reductions of roughly 25% in their opioid-related death rates compared to states with no such laws.
In their first year after implementation of the laws, the 13 states averaged an opiate-related fatality rate 20% lower than those of states without legalized #$%$. The average difference between the two groups of states widened at two and three years out, returned to 20% in year four, then rose to just over 33% in years five and six.
Others may use marijuana in place of benzodiazepine drugs — sedatives that make a fatal overdose much more likely. Still other patients who might initiate opioid medication use — and go on to risk overdose — may never start if they are able to get pain relief from #$%$, the study authors wrote.About 60% of the nation's fatal opioid overdoses occur among patients who have legitimate prescriptions for their medications. The authors wrote that in states where access to #$%$ is legal, legitimate opioid drug users may take lower doses of that prescription pain medication, making overdose less likely.
"That connection may be intrinsically appealing — some might view the idea that people could use a milder drug versus an opiate as an improvement," said Kevin Sabet, director of the University of Florida Drug Policy Institute, in a statement. But the new study suffers from "too many uncertainties" to allow that conclusion, he said.
Dr. Mark Ware, a pain specialist and professor of family medicine at McGill University in Montreal, called the JAMA Internal Medicine study "very interesting, and methodologically robust." But, he added, "there's probably a temptation to extend the findings of this study to far broader conclusions than are justified."
The United States "is conducting a natural experiment" on a national scale, said Ware, who is executive director for the Canadian Consortium for the Investigation of Cannabinoids, an advocate for more research on marijuana's medical potential.
Before physicians and government officials can draw conclusions on the public health benefits of #$%$ laws, he said, they need more detailed studies of how #$%$ users take the drug and how its use affects physicians' prescribing decisions, especially for patients with chronic pain.
This is one of the most undervalued bio plays with little risk IMO. Essentially all P1 complete with high likely hood of meeting end points for such small cohorts. Manufacturing and stability concerns would have been mitigated prior to starting these additional P1s. Pfizer has stated it intends to move forward and refile. FDA now seeks out abuse deterrent products. King and Pfizer have already validated the nPV for Remoxy amongst competition and have done due diligence on IP. Low risk with low price/valuation, seems like a no brainier. I have made my bets, solid play here and look forward to next 6-12 months to triple my investment. Ptie is not a speculative play anymore (but rather a great investment) due to risk/reward profile. Now is the time to invest prior to news being released!
Sentiment: Strong Buy
Pfizer just changed study status from recruiting to Study is on going but not recruiting participants.
I think this is the last of the studies in regards to abuse likeability.
let's hope the manufacturing stability data is good.
Obvious, you really haven't a clue of what this is all about. The drug is abuse-resistant! not what you are saying, it is still the same opiate addicting drug, the abusers just can't break it up and snort it or shoot it up! Just thought I would clear that up for you!