Maryo,
We had a similar problem with Cafergot here in Australia in 2009, when the machine used to manufacture it broke down and the decision was taken by the manufacturer not to re-tool, or replace the very old machine used to manufacture Cafergot.
So many Cafergot users have used compounding Pharmacies here in Oz to have Ergotamine injections, tablets or capsules made for them. I don't know if this service is available in the US, but I assume, with research, that there would be some raw Ergotamine type compound that could be found and made into useable delivery methods and dosages by a compounding Pharmacy.
I hope this helps, maybe not in the US, but it's all I got for ideas from here.
Re: Zyprexa.
I don't know why this information keeps getting posted.
I ran this past my specialist, A Professor of Clinical Phramacology and Headache specialist. He knows drugs and CH, has more than 80 "first in human" molecular structures to his name and has conducted over 800 clinical trials, many in Headache research. His first contribution to Headache as a Pharmacologist was Zolmitriptan (Zomig).
In CH circles, few have his understanding of drugs, how they are thought to work, how they don't work and what is of most efficacy in his many CH patients.
I ran this Olanzapine in CH study by my specialist.
Firstly, despite seeing no plausible way Olanzapine may work in CH, he of course had an open mind. Because nobody knows how CH works, how drugs work, or how drugs MAY work in CH, if at all.
If I wanted to trial Olanzapine, I was welcome to. Regulatory approvals could be obtained through Drug Approvals boards and ethics committees for its appropriate use in my chronic, intractable case. So, thanks for the idea Bob, it was considered and I have tried the drug.
Neither I nor my Specialist were put off by the drug's primary usage. After 70 drug trials in CH myself, I am no longer concerned about a chemical compound's intended usage, I am always however, thoroughly assessed for appropriate use and monitored closely for safety.
My experience with Olanzapine (Zyprexa):
Upon using Zyprexa, of concern to me was the side effect profile - a bad one. Including, but not limited to potential for MASSIVE weight gain. The term "Massive" specifically and medically used by my specialist.
I ballooned around 7kg in a week, it was unbelievable.
Diabetes could become an issue very quickly.
Withdrawal from the drug was terrifying, in my case.
I shook for a week. it took me over a year to lose the weight I gained using Zyprexa. Topiramate is like methamphetamine in the "dopey" department, compared to Zyprexa. Zyprexa turned me into a sleeping, eating, drooling zombie with one of the worst side-effect profiles I have experienced in over 25 years of 70+ drug trials and 35 years chronic CH. Withdrawal from the drug, for me was absolutely terrifying. But that was just me - one patient.
My own meager Zyprexa experiences aside...If long term "off label", or "open label" Olanzapine use for CH were to be continued in the long term, ongoing risk vs benefit assessment would have to be carried out in each individual patient. I'm not alone in that sentiment.
Quote:NPS Medicinewise
GPs urged to routinely assess benefits and harms for patients taking antipsychotics
7 September 2011
Psychotic disorders affect 4% of Australians. Those taking antipsychotic medicines to treat their condition not only bear the burden of disease, but also a significant burden of side effects from the medicines they take. Balancing the benefits and harms of these medicines for each individual represents a constant challenge for GPs.
An Australian survey found that about 80% of people with a psychotic illness taking risperidone or olanzapine reported one or more troublesome side effects and worsened quality of life. Another study found that more than half of those tested had significant risk factors for cardiovascular disease or diabetes.
The latest NPS education program, Balancing benefits and harms of antipsychotic therapy, promotes the safe and effective use of antipsychotic therapy and facilitates GP decision-making about antipsychotics in three conditions: schizophrenia, bipolar disorder and behavioural and psychological symptoms of dementia.
NPS Clinical Adviser, Dr Danielle Stowasser, says GPs need to feel confident to weigh up the benefits and harms of antipsychotic treatment in various conditions, so they can achieve a favourable balance of clinical benefits and adverse effects for each individual.
“The safety and tolerability profile for each person differs. An individual assessment is key in determining if benefits are being achieved in line with anticipated treatment goals, and that any side effects are not outweighing benefits or affecting adherence," says Dr Stowasser
Assessments should encompass a range of symptoms and risk factors for serious adverse effects, including cardiovascular and metabolic risks, and extrapyramidal symptoms.
“It’s also very beneficial to engage patients and their families or carers in recognising and managing adverse effects. These kinds of conversations often translate into a better patient-clinician relationship and may help improve adherence to therapy,” says Dr Stowasser.
However, for people experiencing behavioural and psychological symptoms of dementia, ensuring clinical effectiveness involves a different set of considerations.
“Antipsychotic prescribing is widespread for people with dementia, yet many of the troublesome symptoms such as wandering, shouting and insomnia don’t respond well to treatment with these medicines and the improvements, if any, are often counterbalanced by significant adverse effects. Not only is tolerability often a problem, but there is evidence of an increased risk of stroke and pneumonia,” says Dr Stowasser.
“This NPS program encourages GPs treating people with behavioural and psychological symptoms of dementia to use non-pharmacological therapies as first line whenever possible, and when antipsychotics are prescribed, to review their ongoing need regularly.”
I understand, this is CH we're talking about.
Sometimes the risks of not medicating under the duress of chronic and severe pain outweigh the risks of some medications. Like Verapamil, individualising Zyprexa usage in CH cases would perhaps be appropriate and a decision for a very specialised few to make, one would think.
I also think anyone using this study to support prescription of Zyprexa in CH and approaching their specialist about it should be made aware of the Olanzapine data sheet, for safety and a list of known contraindications and side-effect profile(s).
Let's "assume" that CHers are to use an ~10mg dose, as per the posted study and that patients have Zyprexa indicated for use as an abortive in CH. They will be seeking the fastest mode of delivery - in this case, the sub-lingual wafer, or Orally Disintegrating Tablet (ODT) forms:
Here is the (Australian) Consumer medical Information (CMI) on Zyprexa wafers and tablets:
Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

or

Here is the (Australian) Product Information (PI) on Zyprexa:
Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

or

If both patients and practitioners access these documents before prescribing Olanazapine for use in CH, a more informed risk assessment can be conducted.
An educated patient makes "better" informed decisions.
The study is of only 5 participants, not exactly compelling, long-term evidence for its use in CH. The study shows that Olanzapine was specifically selected for use in those patients with "contraindications to vasoconstrictive drugs", not as a replacement for vasoconstrictive drugs, like Cafergot. Perhaps suggesting, that other well known abortives be tried before resorting to Olanzapine as a first port of call...
Unlike us laymen out here, my specialist was able to access the entire study criteria and parameters.
Allegedly, the selection criteria were pretty slack and there are no controls. The study does not exclude the concomitant use of other preventives, abortives, or factor in spontaneous remission of CH.The trial conclusion is no better than anecdotal, at best.
The study itself received a Journal Impact Factor of just 2.94. Multimedia File Viewing and Clickable Links are available for Registered Members only!! You need to

or
Quote:Olanzapine as an abortive agent for cluster headache.
T D Rozen
Department of Neurology, Jefferson Headache Center/Thomas Jefferson University Hospital, Philadelphia, PA 19107, USA.
Headache The Journal of Head and Face Pain
(Impact Factor: 2.94). 10/2001; 41(8):813-6. DOI:10.1046/j.1526-4610.2001.01148.x
Source: PubMed
Since 2001, when the 5 patient study was conducted, there has been no follow up. The article is from very credible researchers, but somehow they have not seen fit to repeat or further validate their claim to efficacy in CH.
They conclude that Olanzapine "appears to be a good abortive agent for cluster headache". If so, then why no follow up, or further study since 2001?
We (CHers) need more follow up on long term Zyprexa use in any condition for which it is prescribed. I think a clear distinction need be made that the study intended the drug to be used as an alternative, in patients who cannot use vasoconstrictors, before the drug name is thrown out there to anyone seeking relief from CH.
I'm all for options Bob and Zyprexa is clearly one of them, I tried it, under close supervision. But after 3 or 4 near death experiences with my own clinical trials, I'm also for informed patients and appropriate risk vs benefit assessment, underpinned by access to the documents, side-effects and safety record of the drug in question.
Cheers, Ben.