Snorting - Intranasal ketamine developed as a medication

[enquirewithin]

Ketamine, at lower doses than that approved for use as an anesthetic, has been reported in the medical literature to be an effective medication for the treatment of postoperative pain, neuropathic pain and pain during emergency medical procedures....

Javelin has a developed PMI-150, a proprietary nasal formulation of ketamine which is currently under development for treatment of acute moderate-to-severe pain. The Company believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of moderate-to-severe pain.

The results of the meta-analysis demonstrated that intranasal ketamine was effective at relieving moderate-to-severe pain over the 10 to 50 mg dose range with no statistically significant changes to vital signs or arterial oxygen saturation levels. These data were presented at the Department of Defense’s premier medical conference, the Advanced Technology Application for Combat Casualty Care in St. Petersburg, Florida.

http://www.javelinpharmaceuticals.com/pmi150.html

Reputation Comments on this post:

good find

[raven3davis]

SWIM found 130mg ketamine to be a quite effective pain killer. It definitely could have cures moderate to severe pain but SWIM is not sure if 50mg intranasal would suffice.

SWIM has not heard the term intranasal before. Is this the same as snorting or something different?

[enquirewithin]

It might mean some sort of spray, but 50 mg of ketamine ought to relieve pain fairly well. 130mg might make poople too high!

[Richard_smoker]

intranasal is the same as nose-spray.

This doesn't surprise me that a low-dose would be effective against pain. Check out the recovery/addiction folder for my ibogaine-replacement theories and you'll find that most of the literature suggests that ibogaine (the opiate addiction-interupter plant from African Iboga) is a powerful NMDA antagonist. Likewise are other dissociatives like DXM and ketamine. There are research in progress analyzing the effectiveness of low-dose DXM and other NMDA antagonists to relieve pain.

[scotty6435]

Tramadol is listed as treating moderate-severe pain but I'm sure ketamine would only be used for more severe symptoms. I don't understand why it isn't used more although my K knowledge is pretty low.

[JewishNazi]

SWIM likes 100mgs - 150mgs to help with the pain of going to the gym (mainly in left shoulder).

I dont see ketamine ever being used in the real world in that manner as there are already very effective pain-killers that last much longer. Ketamine is addictive (apparently), so spraying some up your nose every hour for days on end most likely wont end well

[yajw]

I met a researcher that is formulating a grant proposal to study the effectiveness of ketamine for migraine headaches. The theory is to see the efficacy of allowing the individual to disassociate oneself from the migraine itself. We're looking at therapeutic levels that allow the individual to function with a migrane occurance, but not enough to put them into an altered state

[Jatelka]

Originally Posted by JewishNazi

I dont see ketamine ever being used in the real world in that manner as there are already very effective pain-killers that last much longer. Ketamine is addictive (apparently), so spraying some up your nose every hour for days on end most likely wont end well

There's quite a lot of interest in K as an analgesic in Palliative Medicine currently, and it's also being trialled for neuropathic pain in diabetes. There is also at least one study looking at K in the setting of limb ischaemia.

Interestingly ketamine reverses morphine tolerance, and so when it is introduced, opiate doses need to reduce by 30-50%

With regards to addiction: Physical tolerance does occur. Psychological dependance also occurs. There does not seem to be a documented physical withdrawal syndrome.

[IHrtHalucingens]

I was taught that if drugs were legitimately and in prescribed doses used to kill pain and that alone you were very unlikely to develop an addiction, is this true or was i misinformed? And if its true then would the same principle apply to the ketamine. As i see it opiates are already very addicting could ketamine be much worse?

[Jatelka]

Originally Posted by IHrtHalucingens

I was taught that if drugs were legitimately and in prescribed doses used to kill pain and that alone you were very unlikely to develop an addiction, is this true or was i misinformed? And if its true then would the same principle apply to the ketamine. As i see it opiates are already very addicting could ketamine be much worse?

Physical tolerance develops. If you were to stop opiates in someone taking them for chronic pain they would develop a physical withdrawal syndrome. They would also likely crave opiates (because they help the pain). If someone takes opiates for pain then the euphoria is not so pronounced (although may still occur). That's the only practical difference between someone in chronic pain and a "recreational" addict. Splitting hairs and arguing about whether the person in pain is "addicted" or not is irrelevant. It's irrelevant because the person in pain requires opiates and (certainly in the palliative setting) is likely to need escalating doses to control that pain.

SWIJ agrees with SWIIHH: Ketamine isn't any worse.

Reputation Comments on this post:

clear response thanks

[JewishNazi]

Originally Posted by jatelka

There's quite a lot of interest in K as an analgesic in Palliative Medicine currently, and it's also being trialled for neuropathic pain in diabetes. There is also at least one study looking at K in the setting of limb ischaemia.

Interestingly ketamine reverses morphine tolerance, and so when it is introduced, opiate doses need to reduce by 30-50%

With regards to addiction: Physical tolerance does occur. Psychological dependance also occurs. There does not seem to be a documented physical withdrawal syndrome.

Good stuff to know, cheers

[enquirewithin]

Trials continue...

Javelin Announces Initial Results of a Pilot Phase II Study Of Intranasal Ketamine In Postoperative Orthopedic Pain
Monday May 1, 4:53 pm ET
CAMBRIDGE, Mass., May 1 /PRNewswire-FirstCall/ -- Javelin Pharmaceuticals, Inc. (OTC Bulletin Board: JVPH - News), a developer of innovative prescription pain medications, today announced preliminary results of a randomized, placebo- controlled pilot Phase II study with Intranasal Ketamine in 60 patients with moderate to severe pain following bunion surgery. Total Pain Relief Scores over three hours (TOTPAR3), the study's primary endpoint, ranged from 44.0 through 54.0 mm hours in patients given active drug compared to 36.3 mm hours in those given placebo. These numerical differences in TOTPAR3 did not reach statistical significance in this trial.

More...

[Richard_smoker]

Originally Posted by jatelka

Physical tolerance develops. If you were to stop opiates in someone taking them for chronic pain they would develop a physical withdrawal syndrome. They would also likely crave opiates (because they help the pain). If someone takes opiates for pain then the euphoria is not so pronounced (although may still occur). That's the only practical difference between someone in chronic pain and a "recreational" addict. Splitting hairs and arguing about whether the person in pain is "addicted" or not is irrelevant. It's irrelevant because the person in pain requires opiates and (certainly in the palliative setting) is likely to need escalating doses to control that pain.

Thanks Jatelka... I say, "forget about pain for a second." After all, this forum is not likely to be seriously perused by those who began with physical pain. (sorry to generalize; exceptions to every rule.)

Funny thing happens when you split THIS hair:

Opiate Addict (who DOES enjoy the 'buzz') differentiated into 2 basic groups:
1. The addict who still loves his/her addiction. and...
2. The addict who wants to stop. REALLY wants to stop.

1. In population #1: Drugs in this class (low-dose dissociatives, like DXM, ketamine, etc) are probably NOT going to be very useful... very much like anti-depressants that decrease obsessive tendencies (SSRI'S) are NOT going to be useful--because both sets of drugs will decrease the highs and lows of the opiates... thus taking away the fun of the highs.

2. Group #2: Probably the more 'important' group because these people actually WANT to stop... whether it be due to a realization of the overall negative effects of opiates on their behavior and mindset; the WD's and the cyclic nature of being in terrible mood vs. good mood; pain vs. euphoria... these people who actually WANT to stop, even though they started and continued to feed their opiate dependency because of the 'fun'--these people will most certainly benefit from the stablizing effects of the low-dose DXM/Ketamine phenomenon.

just my .02... since my last posts on recovery/addiction and the dangers of DXM, i've learned some more very interesting subjective experiences on the use of DXM in opiate-cessation. Very promising, and toxic doses do NOT appear necessary. Thanks all. -Dick

[fastandbulbous]

I've got a bottle (empty now, of course!) with details on the label about the use or oral ketamine linctus (a hideous lemon flavour!) for pain relief. It's 50mg/5ml and is the sort of thing handed out by specialist pain clinics for people who have severe pain that is resistant to most 'ordinary' painkillers - generally neuropathic pain such as phantom limb pain. They also use it to treat the pain in people with severe, extensive burn injuries (if you can't moderate the pain in the CNS with opioids etc, just throw the on/off switch concerning sensory input).

I've found the best analgesic for dealing with my episodes of phantom limb pain is actually cannabis (opioids, anti-epilleptics etc did bog all to allieviate the pain), but once or twice when I've not had any cannabis to use, I've IMed about 80mg of ketamine & obtained rapid, total analgesia. I'd rate it as better then cannabis, but at least I can still get things done if I'm a bit stoned - that's not even a possibility on ketamine (unless it's being a human draught excluder!!)

[mouthwater]

A follow-up:

Javelin Pharmaceuticals Announces Results of FDA Meeting for Nasal Ketamine

Company Plans to File an Initial New Drug Application for Emergency Military and Civilian Use in the United States in 2008

CAMBRIDGE, Mass., Jan 30, 2007 (BUSINESS WIRE) -- Javelin Pharmaceuticals, Inc. (Amex: JAV-News) announced today that its recent meeting with the USFDA and representatives of the US Department of Defense (DOD) provided guidance to complete the development of PMI-150, its proprietary formulation of ketamine for intranasal use. Based on this face-to-face meeting, and summary minutes received January 26, 2007, the Company intends to file a New Drug Application (NDA) for PMI-150 as an emergency analgesic for military and civilian use in 2008.

Dr. Curtis Wright, Javelin's Executive Vice President for Regulatory Affairs and Risk Management, commented, "Javelin is very pleased with the outcome of this meeting. Our clear marching orders for PMI-150 are to meet the needs of DOD and the US emergency medical market in an aggressive timeframe while addressing this drug candidate's ongoing development for broader use in selected medical settings." To this end, Javelin plans to undertake four remaining pharmacokinetic studies and then to file the initial US NDA for PMI-150.

The Company intends to broaden PMI-150's potential initial label as an analgesic for emergency use with future Supplemental New Drug Applications (sNDAs) to increase patient access to the product after initial approval, contingent upon suitable risk assessment. Potential future indications for ketamine beyond acute pain in emergency settings include acute pain in patients resistant to or insensitive to opioids, and pain relief for terminally ill cancer patients in medically supervised settings.

About PMI-150
Javelin is developing PMI-150, a proprietary nasal formulation of ketamine, as an emergency analgesic for military and civilian use. The Company anticipates undertaking additional clinical studies at a later date aimed at broadening PMI-150's potential indications to include treatment of opioid-resistant acute moderate-to-severe pain, including cancer breakthrough pain. The Company believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of moderate-to-severe pain.

Previous randomized, double-blinded, placebo-controlled phase II clinical studies of PMI-150 have demonstrated statistically significant relief of moderate to severe postoperative and breakthrough pain. PMI-150 is fast-acting, with statistically significant pain relief occurring as early as 4 minutes post administration. PMI-150 also appears to be well-tolerated by patients. These results were presented at the American Society for Clinical Pharmacology and Therapeutics in Atlanta, Georgia in April 2002 and the American Society of Clinical Oncology in Orlando, Florida in May 2002. In May 2003, following the presentation of clinical data at the plenary session of the Advanced Technology Application for Combat Casualty Care conference in Orlando, Florida, the U.S. Department of Defense awarded the Company $4 million for the development of PMI-150. This award was based on the need of the military for a fast-acting, non-invasive, and non-sedating alternative to the intravenous and oral medications commonly used for treatment of combat-related injuries. In August 2005, Javelin presented a meta-analysis of three randomized, placebo-controlled studies involving ketamine analgesia for patients with acute moderate-to-severe pain. These results demonstrated that intranasal ketamine was effective at relieving moderate-to-severe pain over the 10 to 50 mg dose range with no statistically significant changes in vital signs or arterial oxygen saturation levels. These data were presented at the Department of Defense's premier medical conference, the Advanced Technology Application for Combat Casualty Care in St. Petersburg, Florida....

Javelin Pharmaceuticals Announces Results of FDA Meeting for Nasal Ketamine

[radiometer]

Thanks for that. I just went and posted it at DrugBuyers, where some people like to throw a hissy fit every time someone asks about ketamine.