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Financial Support NIH Training Grant Fred W. Lyons, Jr. Fellowship from University of Michigan, College of Pharmacy Purdue-Michigan Consortium on Stability of Pharmaceutical Solids Gift from Boehringer Ingelheim.
100 80 % of Patients 60 40 20 Moderately or Minimally Much Improved Improved No Change 43.2% 12.1% 17.4% Placebo n 116 ; Gabapenttin n 109 ; p .001. What are the nature and the persistence of the excreted products derived from semduramicin? Can these products be prejudicial to the environment? 4.7.1. Nature and persistence of the excreted products Excreta from chickens fed a feed supplemented with labelled semduramicin 25ppm ; contained a mean level of 23 mg kg radioactive material. Unchanged semduramicin was 1.59 mg kg. Several other peaks were seen in HPLC traces, but these were not further identified. The major unidentified metabolite accounted for approximately 2.1 mg kg, which is below the 20% of the ingested dose and therefore not considered a "major metabolite" for further assessment. The DT50 of Semduramicin in soil is more than 30 days. No data on degradation in slurry have been submitted. 4.7.2. Effect on environment Since the Kow of semduramicin is low, the risk of bioconcentration and secondary poisoning is expected to be negligible. Using the submitted data, the following NOECs can be established. Table 5 No Observed Effect Concentrations in environmental organisms NOECs or alternative parameter ; 10 mg l 0.33 mg l 100 mg kg 32 mg l 0.32 mg kg 100 mg kg agar ; 4.7.3. Conclusion The Committee considers that, on the basis of these data, harmful effects on the environment are not expected. Species Parameter Test Algae, growth Daphnids, reproduction Earthworms, biomass Rainbow trout, 96h LC50 Plants, soy bean germination Soil microorganisms. Foreign Regulatory Approval Outside the United States, our ability to market our products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities. The foreign regulatory approval process includes all the risks associated with FDA approval described above. The requirements governing conduct of clinical trials and marketing authorization vary widely from country to country. Under European Union regulatory systems, marketing authorizations may be submitted either under a centralized or decentralized procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the application and assessment report, each member state must decide whether to recognize approval. We plan to choose the European regulatory filing procedure that we believe will allow us to obtain regulatory approvals quickly. However, the chosen regulatory strategy may not secure regulatory approvals or approvals of the chosen product indications. In addition, these approvals, if obtained, may take longer than anticipated. We cannot assure you that any of our product candidates will prove to be safe or effective, will receive regulatory approvals, or will be successfully commercialized. Employees As of February 22, 2005, we had 88 employees, 27 of whom are senior management, 22 are in supervisory positions and 39 are non-management. Of the 88 employees, 56 perform scientific and research activities and 26 hold advanced degrees. FACTORS THAT MAY AFFECT OUR BUSINESS There are a number of important factors that could cause our actual results to differ materially from those that are indicated by forward-looking statements. Those factors include, without limitation, those listed below and elsewhere herein. Risks Related to Our Business We expect to incur losses for the foreseeable future and may never become profitable. From the date we began operations in January 2000 through December 31, 2004, we have incurred operating losses of approximately $77.4 million, including operating losses of approximately $34.7 million for the fiscal year ended December 31, 2004, $19.4 million for the fiscal year ended December 31, 2003, and $14.2 million for the fiscal year ended December 31, 2002. Our losses to date have resulted principally from research and development costs related to the development of our product candidates, the purchase of equipment and establishment of our facilities and general and administrative costs related to our operations. We expect to incur substantial losses for the foreseeable future as a result of increases in our research and development costs, including costs associated with conducting preclinical testing and clinical trials, and regulatory compliance activities. Our chances for achieving profitability will depend on numerous factors, including success in: ; developing and testing product candidates achieving milestones under our collaboration agreements receiving regulatory approvals developing proprietary antibiotic products commercializing our products; and ; establishing our competitive position. 20, for example, gabapentin 600. The morbidity of recurrent HCV following liver transplantation has made pre-transplant antiviral therapy a high priority for research. The low accelerating dosage regimen of Everson and colleagues has demonstrated good efficacy but must be replicated in other cohorts and centers. The development of new, nonimmunomodulatory antiviral agents promises to be a significant advance in the treatment of this population. Ultimately, individualization of the anti-viral regimen chosen in each case may lead to better efficacy rates with less adverse drug reactions and side-effects.

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Gabapentin Neurontin ; is a new FDAapproved anticonvulsant that is currently being studied for its potential role as a mood stabilizer. Gabapenyin is an analog of the major inhibitory neurotransmitter in brain gamma-aminobutyric acid GABA ; . Gabaapentin does not appear to directly mimic GABA but is a potent inhibitor of the transporter for GABA and other amino acids. Its precise mechanism of action remains unknown but is approved for use as an adjunct in the treatment of resistant partial seizures that either have or have not become secondarily generalized to full-blown major motor seizures. Thus, as a potentially unique anticonvulsant with actions above and beyond those of more traditional agents in the refractory epilepsies, gabapentin has begun to be studied for its putative mood stabilizing effects in patients with affective disorders. This is based on the indirect evidence of a variety of other anticonvulsant compounds, particularly carbamazepine and valproate, being effective in affective illness even in the absence of seizure disorder. A considerable literature also exists implicating alterations in GABA function in the potential pathophysiology of the affective disorders. Habapentin has a variety of attributes that make it particularly promising for an adjunctive agent. It is not bound to plasma protein and is not metabolized in humans. Absorbed gabapentin is excreted unchanged directly in urine and does not induce hepatic microsomal enzymes. Therefore, the drug is highly compatible with most other agents used in psychopharmacology and no problematic interactions have been noted with a variety of other anticonvulsant agents. Gaabpentin has a relatively short half-life of 5 to 9 hours, and the time to steady state is one to two days. There is some evidence that very high doses of the drug inhibit its own transport into the brain, making it potentially even safer than expected in situations of overdose. Gabapentin comes in pills of 200, 300, and 400 mg which are best initiated with a night-time dosage, as transient drowsiness often accom. Circuit recently noted in drug patent litigation similar to the one before us, "There is no question that settlements provide a number of private and social benefits as opposed to the inveterate and costly effects of litigation." 402 F.3d at 1075. It is well settled that "[w]here there are legitimately conflicting [patent] claims . , settlement by agreement, Schering-Plough and haldol.
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Optimal clinical research design are one of the reasons that bipolar illness funding for clinical trials has markedly declined at the NIMH over the past two decades. Little progress has been made in broadening patient entry criteria and accepting designs other than the parallel group vs. placebo design, which the Food and Drug Administration has traditionally required for drug approval. Given the extreme variability of clinical presentation types, as well as illness patterns and fluctuations in bipolar patients, the traditional parallel group design protocol is extremely difficult to achieve other than in a large, multi-center, expensive collaborative study such as that described by Calabrese. It is encouraging that similar quantitative and qualitative results were observed in the alternative trial design of Frye et al., with a much smaller and more intensively studied patient group. Gabapentin and Bipolar Disorder Dr. T. Young and colleagues reported that in an open study, adjunctive treatment with gabapentn in 30 patients with bipolar disorder was a highly effective mood stabilizer in the majority of patients. Eighty-two percent of patients during a manic phase and 55% during a depressed phase experienced improvement. Nonrapid cyclers tended to have a more robust and sustained response. Ed. Note: These findings are of particular interest because they mirror similar observations of gabappentin in open, adjunctive studies of our patients in the Stanley Foundation Bipolar Network Suppes et al, Journal of Affective Disorders, in press ; but not those of Frye et al. described above, using gqbapentin monotherapy in a double-blind, placebo-controlled clinical trial. Further work is needed in order to reveal the utility and spectrum of action of gabapentin in bipolar illness. The initial data suggest that it is inadequate in monotherapy, but may have clinically relevant effects when used adjunctively.
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Tical Research presented data indicating that gabapentin Neurontin ; was not an effective treatment for acute mania. In a 10-week, double-blind, placebo-controlled trial of adjunctive gabapentin, flexibly dosed between 900 and 3600 mg day, gabapentin was not superior to placebo as an adjunctive treatment for bipolar I symptoms of hypomania, mania, or mixed states. These data are convergent with the data from the NIMH doubleblind study Frye et al., 2000; J Clin Psychopharmacol, in press ; indicating that lamotrigine Lamictal ; was more effective in a group of patients with a variety of refractory affective disorders than either gabapentin or placebo neither of which differed statistically from each other ; . In contrast to Dr. Pande, DR. M. HARDOY et al. of the University of Florence, Italy, reported a 60% moderate to marked response rate for open-label, adjunctive gabapentin in the treatment of bipolar and schizoaffective disorders, a response rate similar to the results from open-label, adjunctive studies in the literature. Gabapentin has also been shown to be effective in some anxiety disorders including social phobia, and is widely used for adjunctive treatment in pain syndromes. Thus, its spectrum of therapeutic efficacy in adjunctive treatment for anxiety and depression associated with bipolar disorder remains to be further delineated. DR. S. HOOPES, private practice, Boise, Idaho ; in a study of lamotrigine in the treatment of bipolar depression and other affective disorders in 218 patients, found that lamotrigine combined well with antidepressants, neuroleptics, lithium, and other anticonvulsants, and produced high rates of response in com and haloperidol. No controlled studies of Lamotrigine or Gabapentine have been conducted, and the only data supporting their use comes from case reports. Lamotrigine has been used successfully in the stabilization of adults with Bipolar Disorder. Its efficacy in ameliorating symptoms of depression and some mixed rapid cycling states has been an extraordinary addition to the available treatments for Bipolar Disorder. Concerns about its potential for inducing rashes, sometimes progressing to the feared Stevens-Johnson syndrome remain, but a slower, more careful titration schedule has drastically reduced the likelihood of these reactions.
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Respiratory complications have been the major cause of morbidity and mortality after pulmonary resection surgery. The thoracic surgical population differs in this from other adult surgical groups where cardiac complications are the commonest cause of morbidity and mortality. Studies before 1990 consistently report a higher rate 1520% ; of major respiratory complications--atelectasis, pneumonia, respiratory failure--following thoracic surgery than cardiac complications such as ischemia and arrhythmia, 1015%.1 This may relate in part to the pattern of recovery of pulmonary function following thoracotomy, which shows a delay in the 2472 hour post-operative period that is not seen with other major surgical incisions.2 The incidence of post-thoracotomy respiratory complications has shown an overall decline in the last decade to 10% while the cardiac complication rate has not changed.3 It is now becoming evident that improvement in post-operative care--specifically pain management--is the major cause of this decline.4 Thoracic surgery patients represent a population of patients whose pain control is arguably the most challenging. Thoracotomy pain is extremely intense, multifactorial, and its location inherently adds insult to respiratory function already compromised by surgery. The incidence of chronic postthoracotomy pain is reported to be 4467%, but the pain is severe only in 25% of these patients.58 Video-assisted thoracic surgery VATS ; , a minimally invasive approach, can significantly reduce post-operative pain but chronic discomfort is still reported in up to 63% of these patients.911 It has also been suggested that women report more post-thoracotomy pain than men and would benefit from improved multimodal analgesic regimens.12 There are multiple sensory afferents that transmit nociceptive stimuli following thoracotomy. These are listed in Table 1.13 Effective pain control is difficult because one analgesic technique is not applicable to all sources. The optimal choice for an individual patient will depend on patient factors contraindications, preferences ; , surgical factors type of incision ; , and system factors available equipment, monitoring, nursing support ; . The ideal post-thoracotomy technique will include three classes of drugs: opioids, non-steroidal anti-inflammatory drugs NSAIDs ; , and local anesthetics. These are evidence-based choices and their use will be discussed. Other choices such as cryoanalgesia, transcutaneous electrical nerve stimulation TENS ; , and the anticonvulsant gabapentin will be mentioned. Systemic Analgesia Opioids Systemic opioids alone are effective in controlling background pain but the acute pain component associated with cough or movement requires plasma and loperamide. Tol H.1, Atalay H.2, Guney I.2, Gokbel H.3, Altintepe L.4, Buyukbas S.5, Bodur S.6, Selcuk N.Y.2, Tonbul H.Z.2, Yeksan M.2, Engin B.1, Turk S.2 Departments of 1Dermatology; 2Nephrology; 3Physiology; Statistics, Selcuk University, Meram School of Medicine, Konya, Turkey; 4 Department of Nephrology, Meram Research and Training Hospital, Konya, Turkey hakkig selcuk .tr Aim: It was aimed to determine possible changes in pruritus, life quality, depression and sleep quality in pruritic haemodialysis HD ; patients with gabapentin therapy. Methods: Fourteen adult HD patients who had histories of pruritus more than 8 weeks were assigned to receive gabapentin 300 mg ; therapy for 8 weeks. The daily pruritus scores using a visual analogue scale were collected for each period of the study during 1 week preceding the trial, the active treatment phase, the placebo phase and the intervening 1-week washout period. Sleep quality was determined with a modified post-sleep inventory, quality of life with a short form of Medical Outcomes Study SF36 ; , depression using the Beck Depression Inventory. Results: The mean pruritus score decreased significantly from 7.6 1.2 to 1.3 1.4, total of post-sleep inventory significantly from 5.8 3.3 to 1.8 with gabapentin therapy. Physical and mental component scales of SF-36 increased, cognitive and somatic depression index decreased with gabapentin. Conclusion: We concluded that beneficial effects of gabapentin therapy on pruritus, quality of life, depression and sleep quality are important clinically in pruritus haemodialysis patients. Gabapentin therapy should be taken into account as a serious choice of therapy in pruritic haemodialysis patients.
The study found that the average daily pain score, as recorded by patients, was significantly lower at the end of the study among those in the gabapentin group, compared to those in the placebo group; treatment with the drug was also associated with significant improvements in mood and quality of life and indomethacin.
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