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Biotech / Medical : Biotech Short Candidates -- Ignore unavailable to you. Want to Upgrade?

To: Biomaven who wrote (63)	6/22/2001 1:30:15 PM
From: tuck	Read Replies (1) \| Respond to of 897

Peter, Nice buy! With the Redux cloud gone, I've got to admit what little I can find on pagoclone looks good. It appears Parke-Davis ran into a brick wall with their panic disorder program, looked around, and found pagoclone with good efficacy versus other treatments and a better side effect profile. Then Warner Lambert got munched, and a few months passed before progress began again. Here's a few links and snips: Mention of market size: interneuron.com The most recent relevant data I could find: >>Efficacy and Safety of Pagoclone in the Treatment of Panic Disorder Richard J. Kavoussi, M.D. 1; E-mail: richard.kavoussi@wl.com Atul C. Pande, M.D. 1 Pagoclone Investigators Team 1 Parke-Davis Pharmaceutical Research, 2800 Plymouth Road, Ann Arbor, MI, 48105 Background: Currently available medication treatments for panic disorder have significant limitations. Pagoclone is a highly potent anxiolytic that acts on GABAA receptors but appears to have much less potency for sedation and dependence-inducing liabilities than benzodiazepines. The objective of this study was to determine whether pagoclone is effective in the treatment of panic disorder. Method: In this multi-center study, 277 out-patients with DSM-IV panic disorder (with or without agoraphobia) were randomized to receive 0.15 mg/d, 0.30 mg/d, 0.60 mg/d, or placebo following a two-week baseline phase. Panic attacks were recorded via daily diaries. The Stanford Sleepiness Scale and the Rickels Withdrawal Checklist were administered to assess daytime sedation and withdrawal symptoms respectively. Results: After eight weeks of treatment the decrease in mean number of panic attacks was greater in all pagoclone treated groups compared to placebo. This difference was statistically significant for pagoclone 0.3 mg/d: mean decrease 3.9 versus 2.3 on placebo (p=0.02). No significant differences between drug and placebo on the Stanford Sleepiness Scale and Rickels Withdrawal Checklist were noted. Conclusion: These results suggest that pagoclone may be helpful for patients with panic disorder. Given that this medication may prove to have advantages over currently available agents, further controlled trials are warranted. Source of Funding: This study was funded by Interneuron Pharmaceuticals, Lexington, MA.<< >>Pande AC; Pollack MH; Crockatt J; Greiner M; Chouinard G; Lydiard RB; Taylor CB; Dager SR; Shiovitz T [Find other articles with these Authors] Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann Arbor, Michigan 48105, USA. atul.pande@wl.com. A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of panic disorder. One hundred three patients were randomly assigned to receive double-blind treatment with either gabapentin (dosed flexibly between 600 and 3,600 mg/day) or placebo for 8 weeks. No overall drug/placebo difference was observed in scores on the Panic and Agoraphobia Scale (PAS) (p = 0.606). A post hoc analysis was used to evaluate the more severely ill patients as defined by the primary outcome measure (PAS score > or = 20). In this population, the gabapentin-treated patients showed significant improvement in the PAS change score (p = 0.04). In patients with a PAS score of 20 or greater, women showed a greater response than men regardless of treatment. Adverse events were consistent with the known side effect profile of gabapentin and included somnolence, headache, and dizziness. One patient experienced a serious adverse event during the study. No deaths were reported. The results of this study suggest that gabapentin may have anxiolytic effects in more severely ill patients with panic disorder.<< And this was the best showing I could find from their own efforts. neuroinvestment.com Neuro's report offers nice nuggets such as burn and royalty rates for precision valuation. This link offers clues into treatment alternatives for Panic Disorder, and other possible keywords for further Medline searches: webmd-practice.medcast.com Here's a competiting anticonvulsive: >>Efficacy of divalproex sodium in patients with panic disorder and mood instability who have not responded to conventional therapy. Can J Psychiatry 1998 Feb;43(1):73-7 (ISSN: 0706-7437) Baetz M; Bowen RC [Find other articles with these Authors] Department of Psychiatry, University of Saskatchewan, Saskatoon. OBJECTIVE: To determine the efficacy of divalproex sodium in the treatment of psychiatric outpatients with treatment refractory panic disorder and comorbid mood instability. METHOD: This was an 8-week, open-trial, flexible-dose outcome study conducted at a tertiary care referral centre. Individuals with panic disorder who failed to respond to a cognitive behavioural treatment program and standard antipanic medication, who also suffered from mood instability, were chosen to participate in the study. Divalproex sodium was administered at a flexible dose to reach serum levels of 300 to 600 mumol/L (45 to 90 ug/ml) unless limited by tolerance. Patients were rated by self- and rater-administered questionnaires that measured the number of panic attacks, the degree of agoraphobic avoidance, the levels of depression, anxiety, and mood swings, and the perceived sense of well being. RESULTS: Thirteen subjects were enrolled in the study, and 10 subjects completed it. Two dropped out early because of the medication's side effects, and 1 was lost within the first month of follow-up. All 10 subjects showed significant improvement in depressive and anxiety symptoms and mood instability. There was also a statistically and clinically significant improvement in panic attacks and measures of quality of life. CONCLUSIONS: These findings suggest that divalproex sodium is useful in the treatment of patients with panic disorder and concomitant mood instability, who are refractory to conventional treatment. Double-blind trials will be required to verify these findings.<< Peter, did you do any digging into the competing treatments under development? I gather IPIC has a head start, if not the best compound out there. Edit: What would give you the itch to sell? Cheers, Tuck