I wish to know all the pharmacies in the U.S. that offer for sale
tri-mix gel, which is a drug used for erectile dysfuction (impotence). The tri-mix
consists of a mixture of phentolamine, prostaglandin E1, and
papaverine. It is normally purchased from compounding pharmacies, and
the more efficacious and tradition form is the injectable.  However,
we wish to find out about the availability of the gel form. 
Furthermore, we would like to find all medical, educational or
instructional articles regarding tri-mix in the gel form.

Hello bouncer4-ga,

You’ve asked a very interesting question. The market for erectile
dysfunction products and medications is huge and there is a huge
collection of Web resources available to help you with researching
every aspect of this topic. There is much more limited information
available on your specific product search – a trimix of phentolamine,
prostaglandin E1, and papaverine in gel form. I was able to find
compounding pharmacists who are able to provide this product as well
as some literature on its history, development, availability and use.
In the course of doing this research I also found resources that will
help you put the trimix-specific information in better context.

======================
COMPOUNDING PHARMACIES
======================

Your quest for trimix and a compounding pharmacist who can provide it
to you may be affected by a recent (May 2002) instruction from the
Food and Drug Administration as a result of a Supreme Court decision.
Compounding pharmacies must adhere to strict regulations and the
instructions are currently under revision.

http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html
Compliance Policy Guide
Compliance Policy Guidance for FDA Staff and Industry1
CHAPTER - 4
SUB CHAPTER - 460
Sec. 460.200 Pharmacy Compounding 
May 2002 – This document provides guidance for FDA Staff and the
pharmaceutical industry on pharmaceutical compounding based on a
recent Supreme Court decision.

I think you will find the FDA’s information helpful for understanding
how compounding pharmacy services are monitored. The International
Academy of Compounding Pharmacists Web site will help you search for
compounding pharmacists. Not all of them will be willing and/or able
to help you with getting a supply of trimix gel. Below I’ve listed
compounding pharmacists that specifically mention on their Web sites
that they are able to give you this service.

http://www.fda.gov/cder/
Food and Drug Administration, Center for Drug Evaluation and Research
http://www.fda.gov/cder/pharmcomp/default.htm
The Practice of Pharmacy Compounding

http://www.iacprx.org/index.html
International Academy of Compounding Pharmacists
http://www.iacprx.org/referral_service/index.html
Help me find a compounding pharmacist
You can use this search engine that will find compounding pharmacists
based on distance from your ZIP code.

http://www.bbpharmacy.com/cp_rx.htm
Compounding Pharmacy
http://www.bbpharmacy.com/intracavernosal.htm#Phentolamine
B&B Pharmacy and Health Care Center
We have the capacity to compound an endless variety of formulations
which meet the needs of physicians and patients. Please call
1-800-231-8905 with any questions.

http://www.bbpharmacy.com/urologists_this_is_what_we_h.htm
For Urologists this is what we have compounded in the past
2. Papaverine, Phentolamine and alprostadil Gel

http://216.239.51.100/search?q=cache:Xha-brfHolwC:www.bbpharmacy.com/impotence.htm+phentolamine+gel&hl=en&ie=UTF-8
Page only in cache
Supplements for Sexual enhancement
Intraurethal gel of PGE1 or tri-mix

http://www.medaus.com/
Medaus is a full-service pharmacy dedicated solely to the preparation
and delivery of compounding medications.
Medaus Pharmacy and Compounding Center
2637 Valleydale Road, Suite 200
Birmingham, Alabama  35244 
Phone: (205) 981-2352 Phone: (800) 526-9183
info@medaus.com
http://www.medaus.com/services.htm
Phentolamine, PGE-l , Papavarine
Urethral inserts

http://www.centralpharmacy.nf.ca/internal/compounded.html
MEDICATIONS COMPOUNDED AS OF THIS DATE BY CENTRAL PHARMACY ON REQUEST
OF PHYSICIANS
Prostaglandin E1 Intraurethral Gel
http://www.centralpharmacy.nf.ca/internal/comments.html
No address or phone number given
If you feel that you or someone you know could benefit from our
compounding services and would like more information, please contact
one of our knowledgeable pharmacists.

http://www.ccc-rx.com/compounded_prods.htm
Creative Compounding Center
1779 W. Genesee
Lapeer, MI 48446
1-800-672-2177
FAX: 1-810-245-4133
E-MAIL: customer_care@ccc-rx.com
We can make medications in non-standard doses, over 100 different
flavors, and in many different forms for administration.  Of these
forms we can make suppositories, injectables, capsules, suspensions,
plo-gels, and also chewable troches.
 
http://www.californiapharmacy.com/store/
California Pharmacy & Compounding Center
307 Placentia Avenue, Suite 102
Newport Beach, CA 92663
949-642-8057
800-575-7776
FAX 949-642-0725
 Our goal is to make it as easy as possible for physicians and
patients to order a custom compounded prescription.

=================
LITERATURE REVIEW
=================

My review of the literature on erectile dysfunction products and
services indicates that that this is a huge market and that
pharmaceutical companies are coming out with new products all the time
because of the wide demand worldwide. Frequently products are
announced and then withdrawn because they need further clinical
research for FDA approval. This is the case with the three ingredients
in the trimix product. No trimix gel has qualified for FDA approval.
The single ingredient versions were withdrawn pending further
research. Below I’m including some articles that review the place of
injectables and gels in the spectrum of available product as well as
information about some of the products that specifically address your
questions. It is clear that pharmaceutical companies are eager to
develop a cream/gel that would be easy to use but so far they’ve had
limited success.

http://www.bioscorpio.com/sexual_dysfunctions.htm
Sexual Dysfunctions -- Erectile Dysfunction (ED):
This is a short article that explains that erectile dysfunction
products represent an extra-large market valued at about $2 billion.

http://www.nlm.nih.gov/medlineplus/impotence.html
MedlinePlus Health Information – Impotence
http://www.nlm.nih.gov/medlineplus/news/fullstory_10849.html
Friday, December 13, 2002
Impotence Still a Taboo Subject for Men

http://www.ijpc.com/
International Journal Pharmaceutical Compounding
http://www.ijpc.com/_pdf/impotent.pdf
Mar/Apr 1999,. Page 134
Prostaglandin E1/Papaverine HCl/Phentolamine Mesylate Injection
Male Impotency and the Compounding Pharmacist
Pages 4-5 – “These shortcomings (of manufactured options for erectile
dysfunctions) were answered by compounding pharmacists who prepared
intraurethral PGE1 gels.” The article goes on to comment about the
latest developments in gel and oral versions of the the product you’re
looking for. “Phentolamine has worked well over the years as an
ingredient in the classic three-drug injections of PGE1, phentolamine
and papaverine.”

http://www1.excite.com/home/health/healthy_sex/article/0,17757,SA_1309,00.html
The Post-Viagra Drug Development 'Pipeline' (Everything Old is New
Again)
Finally, among the old familiar products with new faces, Vasomax, an
oral version of phentolamine, is being developed by Zonagen and
Schering-Plough. Phentolamine has previously been used to treat ED by
direct injection into the erectile tissues of the penis. Clinical
development of Vasomax was suspended in the Fall of 2000 pending
further animal studies to determine whether phentolamine can cause
cancer.

http://www.greyclinic.com/newsletters.htm
New Topical Gel for Erectile Dysfunction Treatment
Now, MacroChem Corp. recently announced that it will present
preclinical and clinical data supporting Topiglan(TM) gel, its
investigational treatment for erectile dysfunction (male impotence),
at the 95th annual meeting of the American Urological Association
(AUA), April 29 through May 4 in Atlanta, GA.

http://www.macrochem.com/site/content/products/topiglan.asp
What is Topiglan®?
The FDA has advised MacroChem that further clinical trials of
Topiglan® have been placed on clinical hold until potential safety
issues regarding a transgenic mouse carcinogenicity study have been
resolved. MacroChem is working with FDA to resolve these issues.

http://www.drmirkin.com/archive/6616.html
The Dr. Gabe Mirkin Show and DrMirkin.com
Report #6616 10/5/95
The Food and Drug Administration has approved marketing of
alprostadil, the first
 ALPROSTADIL TOO EXPENSIVE FOR IMPOTENCE
For more than five years, many urologists have been prescribing a
combination of three drugs, phentolamine, alprostadil and papaverine,
that can cost far less than the new product. (1) A recent report in
the Journal of Urology shows that this triple combination is more
effective than just using two components.(2) The triple combination
may be safer because it contains lower doses of alprostadil.

http://www.jr2.ox.ac.uk/bandolier/booth/SexHlth/Alpro.html
Alprostadil for erectile dysfunction update

http://www.ijp-online.com/archives/1998/030/06/r0367-0378re.pdf
1998 Study
Pharmacotherapy of Male Erectile Disfunction with Sildenafil (Viagra)
Refers to other therapies and clinical trials.

http://www.australianprescriber.com/magazines/vol21no2/erectile.htm
The management of erectile dysfunction
The presently marketed formulation of prostaglandin E1 is
inconvenient. It needs to be kept frozen due to the lability of the
prostaglandin in solution. This makes prostaglandin E1 awkward to use,
especially if the patient must travel. Improved formulations such as a
lyophilised powder and a transurethral gel formulation of
prostaglandin E1 as well as an effective oral medication have been
developed and should become available in the near future.

http://www.bioscorpio.com/database_t.htm
investigational drugs, therapies and vaccines
From this page you may order documents with information covering
investigational products
To purchase documents on-line click on   link attached to selected
document!
The fee is $6 per document.
Documents are delivered by e-mail within 48 hrs upon purchase
Product Development Suspended/Terminated:
Topiglan® Cream (Alpostadil, Prostaglandin E1) (2881) 
Topiglan® Gel (Alpostadil, Prostaglandin E1) (3046)
Vasomax® (Phentolamine Mesylate, Z-MAX) (2089)

http://www.macrochem.com/site/content/products/topiglan.asp
MacroChem is the manufacturer of Topiglan
The FDA has advised MacroChem that further clinical trials of
Topiglan® have been placed on clinical hold until potential safety
issues regarding a transgenic mouse carcinogenicity study have been
resolved. MacroChem is working with FDA to resolve these issues.

http://www.vasomaxnews.com/
Clinical Trials in the US have been put on hold awaiting the results
of a mechanistic study of brown fat proliferation in rats.
Schering-Plough has been given regulatory approval to market the drug
in Mexico and Brazil under the trade name Z-Max. Vasomax has been
cleared for the go ahead of clinical trials in the UK.

http://otc.isu.edu/~das/PRESENTATIONS-2000/Alprostadil.PDF
Idaho State University, College of Pharmacy, Sudip K. Das
PRESENTATIONS-2002 -- Alprostadil
“We feel that the market for topical application has a strong future
if sufficient absorption can be obtained. Current studies show
positive results for this area, but further research needs to be
performed to increase transdermal absorption to therapeutic
concentrations.

http://www.cornellurology.com/cornell/sexualmedicine/ed/drugs.shtml
Cornell University, Joan and Sanford I. Weill Medical College
Sexual Medicine Program -- Erectile Dysfunction
This article summarizes the availability and status of current
treatments.

=======================================================
MEDICAL PORTALS AND RESOURCES FOR ERECTILE DYSFUNCTIONS
=======================================================

http://pc.chronicle.ca/sexmed.html
Sexual Medicine on the Web
This is a large collection of links dealing with the condition.

http://www.nlm.nih.gov/medlineplus/
MedLine Plus Health Information
This is a huge portal site with a very large collection of resources.

http://groups.google.com/groups?hl=en&lr=&ie=UTF-8&oe=UTF-8&group=alt.support.impotence
Group: alt . support . impotence

http://www.library.dal.ca/kellogg/subjects/pharm.htm
Dalhousie University, Halifax, Nova Scotia,
Websites Pertinent to Pharmacy -- Kellogg Health Sciences Library
This site offers a very large collection of Canadian, US and
International pharmacy links.

Please note that this is general information furnished without
specific medical training and I highly recommend that you consult with
your physician about any medical condition and decisions about
appropriate medication and treatment.

bouncer4-ga, I hope that you find this information helpful. Please ask
for clarification if any of it needs further development.

This was a very interesting research project. I wish you well in your
quest.

czh

===============
SEARCH STRATEGY
===============

phentolamine
phentolamine gel
compounding pharmacy
compounding pharmacy "erectile dysfunction" gels

I am writing in reference to your comments about FDA regulation. I
work at a compounding pharmacy and we are in no way regulated by the
FDA. We are regulated by the state board of pharmacy as what we do is
considered "compounding" and not manufacturing.

We mix tri gel at Millr Drug. Call for more info on price, amount
needed and lead time for production. Go to http://www.millerdrug.com/
 to get phone numbers and access to email our compound pharmacist for
answers to specific questions.