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[IP] gastroparesis med article

 <A HREF="http://biz.yahoo.com/bw/001019/ca_questco.html">Yahoo - Questcor 
Reports Results of a Phase II Study of Emitasol in Diabetic Gastroparesis</A>

Thursday October 19, 9:02 am Eastern Time
Press Release
Questcor Reports Results of a Phase II Study of Emitasol in Diabetic 
HAYWARD, Calif.--(BUSINESS WIRE)--Oct. 19, 2000--Questcor Pharmaceuticals 
Inc. (AMEX:QSC - news) announced today the results of the Phase II study of 
Emitasol® (Metoclopramide, Nasal Spray) in the treatment of diabetic 
gastroparesis, a serious complication of diabetes that substantially reduces 
quality of life. The study found encouraging results in terms of safety and a 
preliminary evaluation of efficacy. 

In this open-label, multicenter Phase II study, 89 subjects, diagnosed with 
diabetes and symptoms of gastroparesis, were randomized to three treatment 
groups: 18 subjects received oral metoclopramide at 10 mg q.i.d., 35 received 
Emitasol® (Metoclopramide, Nasal Spray) at 10 mg q.i.d. and 36 received 
Emitasol® at 20 mg q.i.d., for a period of six weeks. Pharmacokinetics, 
safety and preliminary efficacy analyses were performed. 

In summary, the study showed that both Emitasol® (Metoclopramide Nasal Spray) 
and oral metoclopramide were bioavailable when administered to diabetic 
gastroparesis patients. This study in disease state subjects differed from 
previous pharmacokinetic studies which were conducted in normal subjects. The 
trial also suggested that Emitasol® (Metoclopramide Nasal Spray) treatment 
may enhance the clinical response versus oral metoclopramide. No adverse 
events reported were categorized as serious. 

``We are enthusiastic about the potential of Emitasol® in diabetic 
gastroparesis,'' said Charles J. Casamento, chairman and CEO of Questcor. 
``Up to 50% of over 8 million patients with reported diabetes in the U.S. 
present symptoms or evidence of gastroparesis. We plan to commence the Phase 
III study in early 2001. We are also looking forward to extending our 
investigations to other conditions, such as delayed-onset emesis caused by 
chemotherapy, where current therapeutic regimens are inadequate. 
Additionally, we continue to explore new partnership opportunities for the 
marketing of Emitasol® outside the U.S. The intranasal delivery route 
presents specific advantages in terms of compliance and expected 
pharmacological response in patients that experience persistent vomiting and 

Efficacy results were of an exploratory nature due to the design of the 
study, but were positive overall. The subject's response to the treatment was 
assessed at baseline and at weekly intervals by a symptom assessment 
questionnaire (SAQ). Symptoms in the SAQ included nausea, vomiting, anorexia, 
feeling bloated, feeling full after a small meal and persistent fullness 
after eating. The analysis of overall SAQ score reduction for subjects 
completing the study according to the protocol indicated a significantly 
enhanced response for both the 10 mg and 20 mg Emitasol® groups, when 
compared to the oral metoclopramide 10 mg group (p = 0.026 and p = 0.008, 
respectively). In individual symptoms, significant improvements in score were 
observed in the intranasal 20 mg group when compared to the oral 10 mg group 
in anorexia (p = 0.019), persistent fullness (p = 0.003) and feeling full 
after a small meal (p = 0.010). The intranasal 10 mg group showed a 
significantly increased improvement from the oral 10 mg group in feeling full 
after a small meal (p = 0.021). 

The single-dose pharmacokinetic profile of metoclopramide was determined for 
all treatment groups both at the beginning and the end of treatment. The 
bioavailability of metoclopramide following its intranasal administration was 
68% to 83% when compared to the oral route as the AUC0-t for the 10 mg oral, 
10 mg intranasal and 20 mg intranasal doses was 269.5, 224.0 and 366.1 ng/mL, 
respectively (treatment day 1). There were no significant differences in 
terminal half-life and in time to reach maximum concentration (Tmax) among 
the groups. However, there was a lag-time of approximately 20 minutes in the 
absorption of metoclopramide for the oral group in comparison to the 
intranasal groups. 

The safety of both routes of metoclopramide administration was evaluated by 
examination of adverse events, active monitoring of nasopharyngeal symptoms, 
vital signs and hematological and biochemical tests. Seven of the 89 subjects 
discontinued treatment prior to study completion. Those dropping out were 
equally distributed among the three treatment arms of the study. Of the 
adverse events that occurred during the study, none was categorized as 
serious and most were reported as mild. There was no statistical difference 
between the treatment groups in adverse events. Significantly more subjects 
in the intranasal groups reported nasopharynx-related adverse events, mostly 
nasal irritation. All but two of the nasopharyngeal adverse events were 
categorized as mild and none as severe. The incidence of neurological adverse 
events such as sleepiness, nervousness or dizziness was low. Three subjects 
(16.6%) reported such events in the 10 mg oral group, none (0%) in the 10 mg 
intranasal and six subjects (16.6%) in the 20 mg intranasal group. There were 
no extrapyramidal reactions in any subjects. 

``We are pleased with the results of the Phase II study, both in terms of the 
efficacy and safety analyses,'' said Dr. Jonathan Goldsmith, vice president 
of clinical research and regulatory affairs. ``Intranasal delivery of 
pharmaceuticals such as metoclopramide allows the avoidance of the oral route 
and may provide more reliable pharmacological effects in patients 
experiencing gastrointestinal problems. We intend to begin the Phase III 
study as soon as possible, as there is a clinical need to treat patients 
experiencing substantial gastrointestinal signs and symptoms as a consequence 
of their diabetes.'' 

Questcor Pharmaceuticals Inc. is a fully integrated specialty pharmaceutical 
company whose focus is to serve the needs of the acute care and critical care 
hospital market. The company's strategy includes the acquisition and 
marketing of hospital pharmaceutical products, the generation of revenue 
streams from these products and the continued funding of late stage, acute 
care and critical care pharmaceutical research and development programs. As 
part of a strategy to develop its products globally, Questcor has entered 
into contractual relationships with CSC Pharmaceuticals HandelsGmbH of 
Vienna, Austria; Crinos Group of Como, Italy; Dainippon Pharmaceutical Co. 
Ltd., of Osaka, Japan; NutraMax Products Inc. of Gloucester, Mass.; Rigel 
Pharmaceuticals Inc. of South San Francisco, Calif.; Shire Pharmaceuticals 
Group plc of Andover, UK; and Laboratorios Silesia S.A. of Santiago, Chile. 
Questcor was created as a result of the merger, on Nov. 17, 1999, of RiboGene 
Inc. and Cypros Pharmaceutical Corporation. 

Questcor will be hosting a conference call on Thursday, Oct. 19, 2000, at 
4:30 p.m. EST. 

Please call this number to participate: 212/231-6049 

Reservation number: 16664731 

Note: Except for the historical information contained herein, this press 
release contains forward-looking statements that involve risks and 
uncertainties. Such statements are subject to certain factors, which may 
cause the company's results to differ. Factors that may cause such 
differences include, but are not limited to, the company's need for 
additional funding, uncertainties regarding the company's intellectual 
property and other research, development, marketing and regulatory risks, 
and, the ability of the company to implement its strategy and acquire 
products and, if acquired, to market them successfully as well as the risks 
discussed in Questcor's transition report on Form 10-K for the fiscal year 
ended Dec. 31, 1999, the Risk Factor section of Cypros' Registration 
Statement on form S-4 (No. 333-87611), and the company's quarterly reports on 
form 10-Q ended March 31, 2000 and June 30, 2000 respectively, and other 
documents filed with the Securities and Exchange Commission. The risk factors 
and other information contained in these documents should be considered in 
evaluating Questcor's prospects and future financial performance. 



     Questcor Pharmaceuticals Inc.
     Charles J. Casamento, 510/732-5551
     (Chairman, President & CEO)
     Jonathan C. Goldsmith M.D., 510/732-5551
     (VP, Clinical Research & Regulatory Affairs)
     Trout Group
     Jonathan Fassberg, 212/477-9007 ext. 16
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